Endo - Hip E0016542-1

GUDID 00885556754917

CURVED SUTUREFIX GUIDE

Smith & Nephew, Inc.

Surgical drill guide, reusable

• Primary Device ID: 00885556754917
• NIH Device Record Key: ade2987b-2044-420d-b17c-7a0adfe35476
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endo - Hip
• Version Model Number: E0016542-1
• Catalog Number: E0016542-1
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556754917 [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

[00885556754917]

Moist Heat or Steam Sterilization

[00885556754917]

Moist Heat or Steam Sterilization

[00885556754917]

Moist Heat or Steam Sterilization

[00885556754917]

Moist Heat or Steam Sterilization

[00885556754917]

Moist Heat or Steam Sterilization

[00885556754917]

Moist Heat or Steam Sterilization

[00885556754917]

Moist Heat or Steam Sterilization

[00885556754917]

Moist Heat or Steam Sterilization

[00885556754917]

Moist Heat or Steam Sterilization

[00885556754917]

Moist Heat or Steam Sterilization

[00885556754917]

Moist Heat or Steam Sterilization

[00885556754917]

Moist Heat or Steam Sterilization

[00885556754917]

Moist Heat or Steam Sterilization

[00885556754917]

Moist Heat or Steam Sterilization

[00885556754917]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-18
• Device Publish Date: 2019-06-10

Devices Manufactured by Smith & Nephew, Inc.

• 00885556892497 - TRIGEN MAX: 2025-05-16 TRIGEN MAX TIBIA NAIL 8MM X 24CM LEFT
• 00885556892503 - TRIGEN MAX: 2025-05-16 TRIGEN MAX TIBIA NAIL 8MM X 25CM LEFT
• 00885556892510 - TRIGEN MAX: 2025-05-16 TRIGEN MAX TIBIA NAIL 8MM X 26CM LEFT
• 00885556892527 - TRIGEN MAX: 2025-05-16 TRIGEN MAX TIBIA NAIL 8MM X 27CM LEFT
• 00885556892534 - TRIGEN MAX: 2025-05-16 TRIGEN MAX TIBIA NAIL 8MM X 28CM LEFT
• 00885556892541 - TRIGEN MAX: 2025-05-16 TRIGEN MAX TIBIA NAIL 8MM X 29CM LEFT
• 00885556892558 - TRIGEN MAX: 2025-05-16 TRIGEN MAX TIBIA NAIL 8MM X 30CM LEFT
• 00885556892565 - TRIGEN MAX: 2025-05-16 TRIGEN MAX TIBIA NAIL 8MM X 31CM LEFT