UNI E0015752-2

GUDID 00885556706657

MODIFIED FEMORAL UNI SIZERS - LL/RM

Smith & Nephew, Inc.

Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable

• Primary Device ID: 00885556706657
• NIH Device Record Key: 293f2022-0193-4bef-8c53-296e61f510d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNI
• Version Model Number: E0015752-2
• Catalog Number: E0015752-2
• 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	00885556706657 [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

[00885556706657]

Moist Heat or Steam Sterilization

[00885556706657]

Moist Heat or Steam Sterilization

[00885556706657]

Moist Heat or Steam Sterilization

[00885556706657]

Moist Heat or Steam Sterilization

[00885556706657]

Moist Heat or Steam Sterilization

[00885556706657]

Moist Heat or Steam Sterilization

[00885556706657]

Moist Heat or Steam Sterilization

[00885556706657]

Moist Heat or Steam Sterilization

[00885556706657]

Moist Heat or Steam Sterilization

[00885556706657]

Moist Heat or Steam Sterilization

[00885556706657]

Moist Heat or Steam Sterilization

[00885556706657]

Moist Heat or Steam Sterilization

[00885556706657]

Moist Heat or Steam Sterilization

[00885556706657]

Moist Heat or Steam Sterilization

[00885556706657]

Moist Heat or Steam Sterilization

[00885556706657]

Moist Heat or Steam Sterilization

[00885556706657]

Moist Heat or Steam Sterilization

[00885556706657]

Moist Heat or Steam Sterilization

[00885556706657]

Moist Heat or Steam Sterilization

[00885556706657]

Moist Heat or Steam Sterilization

[00885556706657]

Moist Heat or Steam Sterilization

[00885556706657]

Moist Heat or Steam Sterilization

[00885556706657]

Moist Heat or Steam Sterilization

[00885556706657]

Moist Heat or Steam Sterilization

[00885556706657]

Moist Heat or Steam Sterilization

[00885556706657]

Moist Heat or Steam Sterilization

[00885556706657]

Moist Heat or Steam Sterilization

[00885556706657]

Moist Heat or Steam Sterilization

[00885556706657]

Moist Heat or Steam Sterilization

[00885556706657]

Moist Heat or Steam Sterilization

[00885556706657]

Moist Heat or Steam Sterilization

[00885556706657]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-06-26
• Device Publish Date: 2017-11-09

On-Brand Devices [UNI]

• 00885556706657: MODIFIED FEMORAL UNI SIZERS - LL/RM
• 00885556706640: MODIFIED FEMORAL UNI SIZERS - LM/RL
• 00885556699904: COATED BABY LANE FORCEPS
• 00885556753682: ZUK SPACER BLOCK - 11MM
• 00885556753675: ZUK SPACER BLOCK - 9MM
• 00885556887608: TIBIAL ANCHOR GUIDE 4/5/6 +0.5MM R
• 00885556887592: TIBIAL ANCHOR GUIDE 4/5/6 +0.5MM L
• 00885556887585: TIBIAL ANCHOR GUIDE 1/2/3 +0.5MM R
• 00885556887578: TIBIAL ANCHOR GUIDE 1/2/3 +0.5MM L
• 00885556887561: TIBIAL ANCHOR PILOT CUTTER +0.5MM
• 00885556887554: LONG TIBIAL ANCHOR PILOT CUTTER +0.5MM
• 00885556887547: TIBIAL ANCHOR GUIDE 4/5/6 +0.5MM R
• 00885556887530: TIBIAL ANCHOR GUIDE 4/5/6 +0.5MM L
• 00885556887523: TIBIAL ANCHOR GUIDE 1/2/3 +0.5MM R
• 00885556887516: TIBIAL ANCHOR GUIDE 1/2/3 +0.5MM L
• 00885556887509: TIBIAL ANCHOR PILOT CUTTER +0.5MM
• 00885556887493: LONG TIBIAL ANCHOR PILOT CUTTER +0.5MM
• 00885556887974: TIBIAL ANCHOR GUIDE 4/5/6 +0.5MM R
• 00885556887967: TIBIAL ANCHOR GUIDE 4/5/6 +0.5MM L
• 00885556887950: TIBIAL ANCHOR GUIDE 1/2/3 +0.5MM R
• 00885556887943: TIBIAL ANCHOR GUIDE 1/2/3 +0.5MM L
• 00885556887936: TIBIAL ANCHOR PILOT CUTTER +0.5MM
• 00885556887929: LONG TIBIAL ANCHOR PILOT CUTTER +0.5MM
• 00885556888063: TIBIAL ANCHOR GUIDE 4/5/6 + 0.5MM R
• 00885556888056: TIBIAL ANCHOR GUIDE 4/5/6 + 0.5MM L
• 00885556888049: TIBIAL ANCHOR GUIDE 1/2/3 + 0.5MM R
• 00885556888032: TIBIAL ANCHOR GUIDE 1/2/3 + 0.5MM L
• 00885556888025: TIBIAL ANCHOR PILOT CUTTER
• 00885556888018: LONG TIBIAL ANCHOR PILOT CUTTER
• 00885556892442: RL TIBIA INTERACTIVE SIZER SZ 6-7
• 00885556892435: RL TIBIA INTERACTIVE SIZER SZ 4-5
• 00885556892428: RL TIBIA INTERACTIVE SIZER SZ 2-3
• 00885556892411: RL TIBIA INTERACTIVE SIZER SZ 0-1
• 00885556892404: LL TIBIA INTERACTIVE SIZER SZ 6-7
• 00885556892398: LL TIBIA INTERACTIVE SIZER SZ 4-5
• 00885556892381: LL TIBIA INTERACTIVE SIZER SZ 2-3
• 00885556892374: LL TIBIA INTERACTIVE SIZER SZ 0-1
• 00885556888636: TIBIAL ANCHOR GUIDE 4/5/6 +0.5MM R
• 00885556888629: TIBIAL ANCHOR GUIDE 4/5/6 +0.5MM L
• 00885556888612: TIBIAL ANCHOR GUIDE 1/2/3 +0.5MM R
• 00885556888605: TIBIAL ANCHOR GUIDE 1/2/3 +0.5MM L
• 00885556888599: TIBIAL ANCHOR PILOT CUTTER +0.5MM
• 00885556888582: LONG TIBIAL ANCHOR PILOT CUTTER +0.5MM
• 00885556918913: RL JII UK TIB TRIAL SZ 7 W/ POST
• 00885556918906: RL JII UK TIB TRIAL SZ 6 W/ POST
• 00885556918890: RL JII UK TIB TRIAL SZ 5 W/ POST
• 00885556918883: RL JII UK TIB TRIAL SZ 4 W/ POST
• 00885556918876: RL JII UK TIB TRIAL SZ 3 W/ POST
• 00885556918869: RL JII UK TIB TRIAL SZ 2 W/ POST
• 00885556918852: RL JII UK TIB TRIAL SZ 1 W/ POST