KNEE E0015746-1

GUDID 00885556708392

TCF FEMORAL DRILL GUIDE

Smith & Nephew, Inc.

Surgical implant template, reusable

• Primary Device ID: 00885556708392
• NIH Device Record Key: 9dfb9e60-2f28-41b6-8509-192b7a1dfb45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KNEE
• Version Model Number: E0015746-1
• Catalog Number: E0015746-1
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556708392 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121393

FDA Product Code

• HRY: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

[00885556708392]

Moist Heat or Steam Sterilization

[00885556708392]

Moist Heat or Steam Sterilization

[00885556708392]

Moist Heat or Steam Sterilization

[00885556708392]

Moist Heat or Steam Sterilization

[00885556708392]

Moist Heat or Steam Sterilization

[00885556708392]

Moist Heat or Steam Sterilization

[00885556708392]

Moist Heat or Steam Sterilization

[00885556708392]

Moist Heat or Steam Sterilization

[00885556708392]

Moist Heat or Steam Sterilization

[00885556708392]

Moist Heat or Steam Sterilization

[00885556708392]

Moist Heat or Steam Sterilization

[00885556708392]

Moist Heat or Steam Sterilization

[00885556708392]

Moist Heat or Steam Sterilization

[00885556708392]

Moist Heat or Steam Sterilization

[00885556708392]

Moist Heat or Steam Sterilization

[00885556708392]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-30

On-Brand Devices [KNEE]

• 00885556717103: SLOTTED QUICK CONNECT HANDLE
• 00885556708392: TCF FEMORAL DRILL GUIDE