Arthrex®

Basic Information

• Brand Name: Arthrex®
• Primary DI: 00888867031265
• Version / Model: AR-4008
• Catalog Number: AR-4008
• 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: 4
• Public Version Date: 2023-01-20
• Public Version Status: Update
• Public Device Record Key: db859802-9aed-4feb-b9bd-f32e396e8c40

Device Description

MENISCAL DART MEASURING PROBE

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
35948	Endoscopic surgical probe	A slender, rod-like, hand-held manual surgical instrument intended to be inserted through an endoscope (e.g., arthroscope, laparoscope) to explore, measure, and/or perform therapeutic procedures during various types of surgical interventions (excludes cryosurgery). It is made of metallic and/or synthetic polymer material. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10888867031262	GS1	Box	5	In Commercial Distribution
Primary	00888867031265	GS1

Customer Contacts

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