MICROLINK

Basic Information

• Brand Name: MICROLINK
• Primary DI: 30845854648906
• Version / Model: ASBR-BB
• Catalog Number: ASBR-BB
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-01
• Public Version: 2
• Public Version Date: 2024-02-12
• Public Version Status: Update
• Public Device Record Key: 056ee9aa-d5ce-499d-82ee-fe0d8caddf0f

Device Description

MICROLINK, ALL-SUTURE BUTTON AND BACKSTOP (RADIOPAQUE)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HTN	WASHER, BOLT NUT	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65038	Orthopaedic fixation suture button	A small, implantable device designed to retain the loop of a ligature/suture to provide additional stability and accurate fixation during orthopaedic procedures, typically internal fixation of fractures with or without additional fixation devices (e.g., bone plates, screws). It can be of various shapes (e.g., H-shaped, round, oblong), made of non-bioabsorbable metallic materials [e.g., titanium (Ti)] and is typically implanted with dedicated implantation instruments; it may be supplied with associated sutures/ligatures.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30845854648906	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K190582	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: KEEP DRY