BICEPTOR 72202359

GUDID 03596010620880

KIT BICEPTOR DISPOSABLES 9MM X 25MM

Smith & Nephew, Inc.

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 03596010620880
• NIH Device Record Key: 2bc77b08-99aa-458c-a8ed-d00eff583afd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BICEPTOR
• Version Model Number: 72202359
• Catalog Number: 72202359
• 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: 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
• 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	03596010620880 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083226

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-29

On-Brand Devices [BICEPTOR]

• 00885556573006: REFURBISHED BICEPTOR DRIVER
• 03596010621535: BICEPTOR BIOSURE PK SCREW 9MM X 15MM
• 03596010621528: BICEPTOR BIOSURE PK SCREW 8MM X 15MM
• 03596010621511: BICEPTOR BIOSURE PK SCREW 7MM X 15MM
• 03596010621320: 9.0MM BICEPTOR TAP
• 03596010621313: 8.0MM BICEPTOR TAP
• 03596010621306: 7.0MM BICEPTOR TAP
• 03596010621252: BICEPTOR DRIVER
• 03596010620880: KIT BICEPTOR DISPOSABLES 9MM X 25MM
• 03596010620873: KIT BICEPTOR DISPOSABLES 8MM X 25MM
• 03596010620866: KIT BICEPTOR DISPOSABLES 7MM X 25MM
• 03596010620859: KIT BICEPTOR DISPOSABLES 9MM X 15MM
• 03596010620842: KIT BICEPTOR DISPOSABLES 8MM X 15MM
• 03596010001856: KIT BICEPTOR DISPOSABLES 7MM X 15MM
• 03596010621542: 1.5 MM TENDON DRILL PIN