FAST-FIX 72201493

GUDID 03596010610911

ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT

Smith & Nephew, Inc.

Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 03596010610911
• NIH Device Record Key: 874b5a7d-dc1f-42e1-ae0e-7d7d9c829547
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FAST-FIX
• Version Model Number: 72201493
• Catalog Number: 72201493
• 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: true
• 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	03596010610911 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151105

FDA Product Code

• GAT: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

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: 2015-09-21

On-Brand Devices [FAST-FIX]

• 00885556571064: REFURBISHEDSLOTTED CANNULA
• 00885554032154: TFCC FAST-FIX KIT
• 03596010500618: FAST-FIX ASSY REVERSE CURVE
• 03596010610911: ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT
• 03596010610904: ULTRA FAST-FIX ASSEMBLY - STRAIGHT
• 03596010597236: ULTRA FAST-FIX AB ASSEMBLY - REV CURVE
• 03596010597229: ULTRA FAST-FIX AB ASSEMBLY - CURVED
• 03596010597212: ULTRA FAST-FIX ASSY - REVERSE CURVE
• 03596010597205: ULTRA FAST-FIX ASSEMBLY - CURVED
• 03596010529589: SLOTTED CANNULA
• 03596010597243: ULTRA FAST-FIX KNOT PUSHER/SUTURE CUTTER STRAIGHT
• 00885556780800: FST FIX FLX REV CRVD INSRTR BNDR CANN ST
• 00885556772737: FAST FIX FLX CRVD INSRTR BNDR CANN SET
• 00885556804711: FF FLEX RVRS CRVD INSTR
• 00885556804704: FF FLEX CRVD INSTR
• 03596010449917: FAST-FIX CURVED NEEDLE ASSEMBLY
• 03596010449900: FAST-FIX ASSEMBLY
• 03596010501998: FST-FX CRVD KNT PSHR STR CTR
• 03596010450104: KNOT PUSHER/SUTURE CUTTER STER. PAK