Arthrex®

Basic Information

• Brand Name: Arthrex®
• Primary DI: 00888867019867
• Version / Model: AR-1591
• Catalog Number: AR-1591
• Company Name: ARTHREX, INC.
• Labeler DUNS: 131747628
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-29
• Public Version: 2
• Public Version Date: 2019-08-05
• Public Version Status: Update
• Public Device Record Key: ba047b71-5dee-49b3-bf72-5aee50bb5c68

Device Description

DETERMINATOR GRAFT LENGTH GUIDE

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
63000	Ligament graft sizer, invasive	A sterile, invasive, surgical device intended to be used to measure the approximate length of graft (autograft or allograft) required to be harvested during an anterior cruciate ligament (ACL) repair. It is typically in the form of a synthetic cord with adjustable beads designed to mark the appropriate length in situ; it is not intended for implantation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00888867019867	GS1

Customer Contacts

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