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ONE TRAY® has a towering list of validations. If you have any questions about the validations below please Contact Us

HIGHPOWER

1311-664

3/13/14

30 Day Event Related Shelf Life Study Of The One Tray Rigid Container Following Pre-Vacuum Steam Sterilization at 132C For 4 Minutes

1407-390

2/16/15

Pre-Vacuum Steam Thermal Profile Study Of The One Tray Rigid Container Model M2408 132C (270F) For 4 Minutes

1407-391

2/16/15

Pre-Vacuum Steam Thermal Profile Study Of The One Tray Rigid Container Model M2104 132C (270F) For 4 Minutes

1407-392

2/5/15

Sterilization Efficacy Study Of The One Tray Rigid Container Model M2408 132C (270F) For 4 Minutes

1407-393

3/19/15

STERILIZATION EFFICACY STUDY OF THE ONE TRAY® RIGID CONTAINER MODEL M2104 132°C (270°F) FOR 4 MINUTES

1407-394

10/7/16

365 DAY EVENT RELATED SHELF LIFE STUDY OF THE ONE TRAY® RIGID CONTAINER MODEL M2408 132°C (270°F) FOR 4 MINUTES

1407-395

9/17/15

180 DAY EVENT RELATED SHELF LIFE STUDY OF THE ONE TRAY® RIGID CONTAINER MODEL M2104 132°C (270°F) FOR 4 MINUTES

1407-396

3/19/15

MICROBIAL AEROSOL CHALLENGE OF ONE TRAY® RIGID CONTAINER FOLLOWING PRE-VACUUM STEAM STERILIZATION AT 132°C FOR 4 MINUTES

1407-397

4/8/15

MICROBIAL AEROSOL CHALLENGE OF ONE TRAY® RIGID CONTAINER MODEL M2104 FOLLOWING PRE-VACUUM STEAM STERILIZATION AT 132°C FOR 4 MINUTES

1407-398

2/16/15

MOISTURE STERILITY VALIDATION OF THE ONE TRAY® RIGID CONTAINER MODEL M2408 132°C (270°F) FOR 4 MINUTES

1407-399

3/19/15

MOISTURE STERILITY VALIDATION OF THE ONE TRAY® RIGID CONTAINER MODEL M2104 132°C (270°F) FOR 4 MINUTES

1407-400

3/31/15

MECHANICAL CLEANING VALIDATION OF THE ONE TRAY® RIGID CONTAINER SYSTEM PROTEIN ANALYSIS

1407-401

3/31/15

MECHANICAL CLEANING VALIDATION OF THE ONE TRAY® RIGID CONTAINER SYSTEM TOTAL ORGANIC CARBON (TOC) ANALYSIS

1407-402

5/1/15

STERILIZATION EFFICACY STUDY OF THE ONE TRAY® RIGID CONTAINER MODEL M2408 132°C (270°F) FOR 4 MINUTES

1407-403

12/31/15

STEAM PRE-VACUUM EFFICACY VALIDATION OF THE STRYKER SPINE ES2 TOP INSTRUMENT TRAY WITHIN A ONE TRAY® RIGID CONTAINER 132°C FOR 4 MINUTES

1409-541

10/6/14

STEAM PRE-VACUUM THERMAL PROFILE FEASIBILITY STUDY OF THE ONE TRAY 134°C FOR 3 MINUTES

1502-56

5/27/15

STERILIZATION EFFICACY STUDY OF THE ORTHO DEVELOPMENT® BALANCED KNEE FEMORAL AND TIBIAL INSTRUMENT TRAYS WITHIN ONE TRAY® RIGID CONTAINER MODEL M2408 132°C (270°F) FOR 4 MINUTES

1505-302

12/17/15

STERILIZATION EFFICACY STUDY OF THE MEDTRONIC WORST CASE INSTRUMENT KIT WITHIN ONE TRAY® RIGID CONTAINER MODEL M2408 132°C (270°F) FOR 4 MINUTES

1508-579

12/24/15

MEM ELUTION CYTOTOXICITY TESTING OF THE ONE TRAY® RIGID CONTAINER

1511-741

1/7/16

STERILIZATION EFFICACY STUDY OF THE STELKAST INSTRUMENT SET WITHIN ONE TRAY® RIGID CONTAINER MODEL M2408 132°C (270°F) FOR 4 MINUTES

1606-349

10/6/16

STERILIZATION VALIDATION OF THE SERENGETI® MINIMALLY INVASIVE RETRACTOR SYSTEM WITHIN ONE TRAY® RIGID CONTAINER MODEL M2408 132°C (270°F) FOR 4 MINUTES

1606-366

7/8/16

STEAM PRE-VACUUM MOISTURE RETENTION OF THE ONE TRAY® RIGID CONTAINER 132°C FOR 4 MINUTES

1611-711 Revision A

1/16/17

STERILIZATION VALIDATION OF THE ONE TRAY® RIGID CONTAINER GRAVITY 132°C (270°F) FOR 34 MINUTES

1612-730, Revision A

1/23/17

STERILIZATION VALIDATION OF THE SMITH AND NEPHEW ASMOC RICHARDS CLASSIC HIP INSTRUMENT TRAY WITHIN ONE TRAY® RIGID CONTAINER MODEL M2408 STEAM PRE-VACUUM 132°C (270°F) FOR 4 MINUTES

1705-284

6/20/17

EVENT RELATED SHELF LIFE STUDY OF THE ONE TRAY® RIGID CONTAINERS 132°C (270°F) FOR 4 MINUTES

1706-380

8/18/17

STERILIZATION VALIDATION OF THE WORST CASE ORTHODRIVE SET WITHIN ONE TRAY® RIGID CONTAINER MODEL M2408 STEAM PRE-VACUUM 132°C (270°F) FOR 4 MINUTES

1802-100

4/23/18

THERMAL PROFILE STUDY OF THE ONE TRAY® M2408 with Filter Lot# 054-1712-01 PRE-VACUUM STEAM 132°C (270°F) FOR 4 MINUTES

1802-99

5/16/18

STERILIZATION VALIDATION OF THE ONE TRAY® M2408 WITH FILTER LOT# 054-1712-01 PRE-VACUUM STEAM 132°C (270°F) FOR 4 MINUTES

1806-421

4/10/19

30 DAY EVENT RELATED SHELF LIFE STUDY OF THE ONE TRAY® RIGID CONTAINER MODEL M2408 STEAM PRE-VACUUM 132°C (270°F) FOR 4 MINUTES

1908-476

9/30/19

THERMAL PROFILE OF THE ONE TRAY® RIGID CONTAINER PRE-VACUUM STEAM, 132°C (270°F) FOR 4 MINUTES

1908-477

10/4/19

STERILIZATION VALIDATION OF THE ONE TRAY® RIGID CONTAINER WITH MMCCS NOT ORGANIZED (LOOSE NOT PLACED IN BRACKETS) PRE-VACUUM STEAM, 132°C (270°F) FOR 4 MINUTES

1909-617

12/13/19

14-DAY EVENT RELATED SHELF LIFE STUDY OF THE ONE TRAY® RIGID CONTAINER MODEL M2408 STEAM PRE-VACUUM 132°C (270°F) FOR 4 MINUTES

1909-617-1

12/13/19

14-DAY EVENT RELATED SHELF LIFE STUDY OF THE ONE TRAY® RIGID CONTAINER MODEL M2408 STEAM PRE-VACUUM 132°C (270°F) FOR 4 MINUTES

1909-617-2

12/13/19

14-DAY EVENT RELATED SHELF LIFE STUDY OF THE ONE TRAY® RIGID CONTAINER MODEL M2408 STEAM PRE-VACUUM 132°C (270°F) FOR 4 MINUTES

1909-617-3

12/13/19

14-DAY EVENT RELATED SHELF LIFE STUDY OF THE ONE TRAY® RIGID CONTAINER MODEL M2408 STEAM PRE-VACUUM 132°C (270°F) FOR 4 MINUTES

1909-617-4

12/13/19

14-DAY EVENT RELATED SHELF LIFE STUDY OF THE ONE TRAY® RIGID CONTAINER MODEL M2408 STEAM PRE-VACUUM 132°C (270°F) FOR 4 MINUTES

1909-617-5

12/13/19

14-DAY EVENT RELATED SHELF LIFE STUDY OF THE ONE TRAY® RIGID CONTAINER MODEL M2408 STEAM PRE-VACUUM 132°C (270°F) FOR 4 MINUTES

2001-34

6/2/20

STERILIZATION VALIDATION OF THE STRYKER MAKO/TRIATHLON INSTRUMENT SET WITHIN A ONE TRAY® RIGID CONTAINER (UNORGANIZED) STEAM PRE-VACUUM, 132°C (270°F) FOR 4 MINUTES

2002-153

6/16/20

STERILIZATION VALIDATION OF THE STRYKER MAKO/TRIATHLON INSTRUMENT SET # 1 WITH MICS WITH EZ-TRAX™ TRANSPORTATION/STERILIZATION CASSETTE (ORGANIZED) STEAM PRE-VACUUM, 132°C (270°F) FOR 4 MINUTES

2002-154

6/16/20

STERILIZATION VALIDATION OF THE STRYKER MAKO/TRIATHLON UNIVERSAL TKA WITH EZ-TRAX™ TRANSPORTATION/STERILIZATION CASSETTE (ORGANIZED) STEAM PRE-VACUUM, 132°C (270°F) FOR 4 MINUTES

2006-448

9/17/20

TRANSPORTATION EVALUATION OF SOILED DEVICES WITHIN ONE TRAY® RIGID CONTAINER

2007-557

9/15/20

STERILIZATION VALIDATION OF THE EZ-TRAX™ ZIMMER G7® ACETABULAR & TAPERLOC® CONTAINMENT DEVICE (UNORGANIZED) STEAM PRE-VACUUM, 132°C (270°F) FOR 4 MINUTES

2007-558

10/19/20

STERILIZATION VALIDATION OF THE ZIMMER PERSONA TOTAL KNEE SET WITH EZ-TRAX™ TRANSPORTATION/STERILIZATION CASSETTE (UNORGANIZED) STEAM PRE-VACUUM, 132°C (270°F) FOR 4 MINUTES

2009-631

10/25/20

TRANSPORTATION EVALUATION WITH A 2-DAY EVENT RELATED SHELF LIFE STUDY OF THE ONE TRAY® RIGID CONTAINER MODEL M2404 STEAM PRE-VACUUM 132°C (270°F) FOR 4 MINUTES

2103-129

6/23/21

STERILIZATION VALIDATION OF THE MICROPORT ORTHOPEDICS WORST-CASE INSTRUMENT SET WHEN PROCESSED IN THE EZ TRAX CONTAINMENT DEVICE STEAM PRE-VACUUM, 132°C (270°F) FOR 4 MINUTES

2106-353

8/23/21

48-HOUR EVENT RELATED SHELF-LIFE STUDY OF THE ONE TRAY® RIGID CONTAINER MODEL, M2408 STEAM PRE-VACUUM, 132°C (270°F) FOR FOUR (4) MINUTES

0411-56

3/14/05

One Tray Internal Container F0 Lethality and Thermal Profile Study

0411-56 Addendum A

3/5/05

One Tray Internal Container Thermal Profile Study

0412-68

5/27/05

One Tray Shelf Life Study

0503-28

4/28/05

One Tray Internal Container F0 Lethality and Thermal Profile Study Prevacuum

0503-29

5/23/05

One Tray Rapid Sterilization Half Cycle Steam Prevacuum Validation

0505-46

5/9/05

One Tray Moisture Rentention Study Prevacuum

0505-58

6/15/05

One Tray Half Cycle Steam Gravity Validation 11″x 24″x 5″ Base with 11″x 24″ x 2.5″ Lid

0507-84

8/29/05

Sterility Maintenance and Microbial Barrier Testing of Package Integrity for the One Tray Container System

0601-06

2/9/06

One Tray Moisture Sterility Study Gravity & Prevacuum

Gibralter

PO18110-00

10/24/14

Validation of Pulsed Pre-Vacuum Moist Heat Sterilization for the Biomet 

TOXIKON

19-01871-G1

6/20/19

l929 Mem Elution Test – ISO

GENESYS SPINE

1607-386

10/20/16

Sterilization Validation of Genesys Spine Implant & Insturment Sets in Rigid Sealed Sterilization Container

NAMSA

N112197

10/20/11

Steam Sterilization Feasibility Study for the Traithlon (Precision) Case 2 (Trays 1 and 2)

STRYKER

REUS-fm-50041 REV. C

10/20/10

Technicians Summary for Moist Heat (Steam) Sterilization Validation

REUS-fm-50805 REV. B

8/6/10

Technicians Summary for Dry Time Validation