MINITAC / DURABRAID 7210295

GUDID 03596010533012

MINI TAC TI 2.0 SUTURE ANCH W/TWO DURA

Smith & Nephew, Inc.

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 03596010533012
• NIH Device Record Key: b76f659b-a2f3-4118-b53d-274691aa3c83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MINITAC / DURABRAID
• Version Model Number: 7210295
• Catalog Number: 7210295
• 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: true
• 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)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010533012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000797

FDA Product Code

• JDR: STAPLE, FIXATION, BONE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-30

On-Brand Devices [MINITAC / DURABRAID]

• 03596010585998: MINITAC 2.0 DURABRAID
• 03596010533012: MINI TAC TI 2.0 SUTURE ANCH W/TWO DURA
• 03596010533029: MINITAC TI 2.0 HS STR ANCHR 2 DRBRD NDL