T-FIX 014762

GUDID 03596010026279

DRILLS T-FIX RCG NON-STERILE

Smith & Nephew, Inc.

Fluted surgical drill bit, reusable

• Primary Device ID: 03596010026279
• NIH Device Record Key: 9294b6ce-67bf-407f-87d4-24800ee445cf
• Commercial Distribution Discontinuation: 2022-03-17
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: T-FIX
• Version Model Number: 014762
• Catalog Number: 014762
• 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: true
• 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
• 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	03596010026279 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K925573

FDA Product Code

• HRX: ARTHROSCOPE

Sterilization

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

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

[03596010026279]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-03-18
• Device Publish Date: 2016-04-12

On-Brand Devices [T-FIX]

• 03596010026934: T-FIX SUTURE BAR SNGL SUTURE
• 03596010026927: T-FIX SUTURE BAR SNGL SUTURE
• 03596010446114: T-FIX RCG STERILE PAC
• 03596010026910: T-FIX SUTURE BAR DBL SUTURE
• 03596010026279: DRILLS T-FIX RCG NON-STERILE
• 03596010402295: CUTTER SUTURE T-FIX
• 23596010026099: T-FIX 1.8MMX9MM (BOX 2) STR