JOURNEY II UNI 74036063

GUDID 00885556691779

JOURNEY II UNI MED TIBIA INSERT TRIAL SZ 7-8 13MM

Smith & Nephew, Inc.

Knee tibia prosthesis trial

• Primary Device ID: 00885556691779
• NIH Device Record Key: 1c9cdee5-f4d8-4eb7-a42d-7763c0757ca9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JOURNEY II UNI
• Version Model Number: 74036063
• Catalog Number: 74036063
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
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• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
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• Phone: +1(800)238-7538
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• Phone: +1(800)238-7538
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• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
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• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
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• Phone: +1(800)238-7538
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• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
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• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
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• Phone: +1(800)238-7538
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556691779 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190085

FDA Product Code

• HSX: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

[00885556691779]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-21
• Device Publish Date: 2019-06-13

On-Brand Devices [JOURNEY II UNI]

• 00885556709702: ANKLE CLAMP
• 00885556709696: TIBIAL ALIGNMENT TUBE
• 00885556706787: TIBIAL SHIM RM/LL - CAPTURED
• 00885556706770: TIBIAL SHIM LM/RL - CAPTURED
• 00885556706763: TIBIAL SHIM RM/LL - UNCAPTURED
• 00885556706756: TIBIAL SHIM LM/RL - UNCAPTURED
• 00885556706749: TIBIAL HEAD RM/LL
• 00885556706732: TIBIAL HEAD LM/RL
• 00885556706725: SPOON - 3MM
• 00885556706718: SPOON - 2MM
• 00885556706701: SPOON - 1MM
• 00885556706695: CONNECTOR - 8MM
• 00885556706688: ANKLE CLAMP
• 00885556706671: TIBIAL ALIGNMENT TUBE
• 00885556696668: NON ROTATING TIBIAL STYLUS 6MM / 8MM
• 00885556696651: NON ROTATING TIBIAL STYLUS 2MM / 4MM
• 00885556686935: UNI FEMORAL TRIAL IMPACTOR / HOLDER
• 00885556696569: TIBIA CONNECTOR 8 MM CLOSED ALTERNATE
• 00885556696453: LM/RL MODULAR SHIM CAPTURED
• 00885556696446: LM/RL MODULAR SHIM UNCAPTURED
• 00885556696439: RM/LL MODULAR SHIM CAPTURED
• 00885556696422: RM/LL MODULAR SHIM UNCAPTURED
• 00885556696415: RM/LL TIBIA RESECTION GUIDE ALTERNATE
• 00885556696408: LM/RL TIBIA RESECTION GUIDE ALTERNATE
• 00885556696293: FIXED ANKLE CLAMP
• 00885556692424: JOURNEY II UNI LAT TIBIA INSERT TRIAL SZ 4-5 11MM
• 00885556692271: 17MM PIN - NON STERILE
• 00885556692264: JOURNEY II UNI FEMORAL TRIAL HOLDER
• 00885556692257: FEMORAL FREE IMPACTOR
• 00885556692240: 3.5mm LOCKING HEX T-HANDLE
• 00885556692233: FEMORAL PEG DRILL
• 00885556692226: JOURNEY II UNI TIBIA SIZING HOOK
• 00885556692202: TIBIA FREE IMPACTOR
• 00885556692196: INSERT IMPLANT LOCKING TOOL
• 00885556692127: KEEL PUNCH
• 00885556691946: JOURNEY II UNI MED TIBIA INSERT TRIAL SZ 9-10 14MM
• 00885556691939: JOURNEY II UNI MED TIBIA INSERT TRIAL SZ 9-10 13MM
• 00885556691922: JOURNEY II UNI MED TIBIA INSERT TRIAL SZ 9-10 12MM
• 00885556691915: JOURNEY II UNI MED TIBIA INSERT TRIAL SZ 9-10 11MM
• 00885556691908: JOURNEY II UNI MED TIBIA INSERT TRIAL SZ 9-10 10MM
• 00885556691892: JOURNEY II UNI MED TIBIA INSERT TRIAL SZ 9-10 9MM
• 00885556691885: JOURNEY II UNI MED TIBIA INSERT TRIAL SZ 9-10 8MM
• 00885556691786: JOURNEY II UNI MED TIBIA INSERT TRIAL SZ 7-8 14MM
• 00885556691779: JOURNEY II UNI MED TIBIA INSERT TRIAL SZ 7-8 13MM
• 00885556691762: JOURNEY II UNI MED TIBIA INSERT TRIAL SZ 7-8 12MM
• 00885556691755: JOURNEY II UNI MED TIBIA INSERT TRIAL SZ 7-8 11MM
• 00885556691748: JOURNEY II UNI MED TIBIA INSERT TRIAL SZ 7-8 10MM
• 00885556691731: JOURNEY II UNI MED TIBIA INSERT TRIAL SZ 7-8 9MM
• 00885556691724: JOURNEY II UNI MED TIBIA INSERT TRIAL SZ 7-8 8MM
• 00885556691694: JOURNEY II UNI LAT TIBIA INSERT TRIAL SZ 6-7 14MM