Journey II Uni E0015455-1

GUDID 00885556686935

UNI FEMORAL TRIAL IMPACTOR / HOLDER

Smith & Nephew, Inc.

Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable

• Primary Device ID: 00885556686935
• NIH Device Record Key: 6c3c9202-db76-4624-acc5-2066486e83db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Journey II Uni
• Version Model Number: E0015455-1
• Catalog Number: E0015455-1
• 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
• 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
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556686935 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113038

FDA Product Code

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

Sterilization

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

[00885556686935]

Moist Heat or Steam Sterilization

[00885556686935]

Moist Heat or Steam Sterilization

[00885556686935]

Moist Heat or Steam Sterilization

[00885556686935]

Moist Heat or Steam Sterilization

[00885556686935]

Moist Heat or Steam Sterilization

[00885556686935]

Moist Heat or Steam Sterilization

[00885556686935]

Moist Heat or Steam Sterilization

[00885556686935]

Moist Heat or Steam Sterilization

[00885556686935]

Moist Heat or Steam Sterilization

[00885556686935]

Moist Heat or Steam Sterilization

[00885556686935]

Moist Heat or Steam Sterilization

[00885556686935]

Moist Heat or Steam Sterilization

[00885556686935]

Moist Heat or Steam Sterilization

[00885556686935]

Moist Heat or Steam Sterilization

[00885556686935]

Moist Heat or Steam Sterilization

[00885556686935]

Moist Heat or Steam Sterilization

[00885556686935]

Moist Heat or Steam Sterilization

[00885556686935]

Moist Heat or Steam Sterilization

[00885556686935]

Moist Heat or Steam Sterilization

[00885556686935]

Moist Heat or Steam Sterilization

[00885556686935]

Moist Heat or Steam Sterilization

[00885556686935]

Moist Heat or Steam Sterilization

[00885556686935]

Moist Heat or Steam Sterilization

[00885556686935]

Moist Heat or Steam Sterilization

[00885556686935]

Moist Heat or Steam Sterilization

[00885556686935]

Moist Heat or Steam Sterilization

[00885556686935]

Moist Heat or Steam Sterilization

[00885556686935]

Moist Heat or Steam Sterilization

[00885556686935]

Moist Heat or Steam Sterilization

[00885556686935]

Moist Heat or Steam Sterilization

[00885556686935]

Moist Heat or Steam Sterilization

[00885556686935]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-04-14

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