Arthrex®

Basic Information

• Brand Name: Arthrex®
• Primary DI: 00888867007109
• Version / Model: AR-1291S
• Catalog Number: AR-1291S
• Company Name: ARTHREX, INC.
• Labeler DUNS: 131747628
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-03
• Public Version: 3
• Public Version Date: 2020-12-04
• Public Version Status: Update
• Public Device Record Key: d3a5bb3c-2268-4e9f-9e00-9b2cf6c7b850

Device Description

NDL,SUTRING,NIT W/WIRE LOOP END

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: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61143	Suturing needle, single-use	A cylindrical-shaped, solid, metal instrument intended to be used to insert and pull suture material through tissue (e.g., skin, fascia, serous, vascular, or other tissue/organ) during surgical stitching of tissues. It is available in various lengths, curvatures, diameters, cross-sectional shapes, and distal end forms. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10888867007106	GS1	Box	5	In Commercial Distribution
Primary	00888867007109	GS1

Customer Contacts

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