Suturefix E0016333-1

GUDID 00885556737262

CURVED SUTUREFIX GUIDE

Smith & Nephew, Inc.

Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable

• Primary Device ID: 00885556737262
• NIH Device Record Key: c93cce3d-0dd9-49f8-9c4e-d129a9339938
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Suturefix
• Version Model Number: E0016333-1
• Catalog Number: E0016333-1
• 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	00885556737262 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163034

FDA Product Code

• MBI: Fastener, fixation, nondegradable, soft tissue

Sterilization

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

[00885556737262]

Moist Heat or Steam Sterilization

[00885556737262]

Moist Heat or Steam Sterilization

[00885556737262]

Moist Heat or Steam Sterilization

[00885556737262]

Moist Heat or Steam Sterilization

[00885556737262]

Moist Heat or Steam Sterilization

[00885556737262]

Moist Heat or Steam Sterilization

[00885556737262]

Moist Heat or Steam Sterilization

[00885556737262]

Moist Heat or Steam Sterilization

[00885556737262]

Moist Heat or Steam Sterilization

[00885556737262]

Moist Heat or Steam Sterilization

[00885556737262]

Moist Heat or Steam Sterilization

[00885556737262]

Moist Heat or Steam Sterilization

[00885556737262]

Moist Heat or Steam Sterilization

[00885556737262]

Moist Heat or Steam Sterilization

[00885556737262]

Moist Heat or Steam Sterilization

[00885556737262]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-04
• Device Publish Date: 2019-01-04

On-Brand Devices [Suturefix]

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• 00885556660133: SUTUREFIX GUIDE WITH MODIFIED TIP
• 00885556653364: MODIFIED SUTUREFIX GUIDE
• 00885556706466: SUTUREFIX GD FR ULTRA STRT DEV XL LNGTH
• 00885556706459: SUTUREFIX GUIDE ULTRA STRT DEV S LNGTH