Arthrex®

Basic Information

• Brand Name: Arthrex®
• Primary DI: 00888867324916
• Version / Model: AR-9673-30A
• Catalog Number: AR-9673-30A
• Company Name: ARTHREX, INC.
• Labeler DUNS: 131747628
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-21
• Public Version: 2
• Public Version Date: 2024-02-29
• Public Version Status: Update
• Public Device Record Key: 3ba50580-3dec-4343-aaea-e3874b0f8489

Device Description

DEFECT GAUGE, Ø30MM GRAFT ANGLE LEG

Device Characteristics

• Single Use: No
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64767	Glenoid defect sizer	A manual orthopaedic surgical instrument intended to be placed on the surface of a defective glenoid fossa to measure the angle (slope) of its bone defect for selection of an appropriately-sized glenoid reamer and/or prosthesis (not included) prior to glenoid repair/replacement. It is intended to be locked into a holder (not included) and has two arms of different lengths for angle measurement; it is available in various arm lengths. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00888867324916	GS1

Customer Contacts

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