Arthrex®

Basic Information

• Brand Name: Arthrex®
• Primary DI: 10888867007427
• Version / Model: AR-1308
• Catalog Number: AR-1308
• Company Name: ARTHREX, INC.
• Labeler DUNS: 131747628
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2018-07-26
• Public Version: 5
• Public Version Date: 2024-02-29
• Public Version Status: Update
• Public Device Record Key: 3d363e91-3a73-4fe2-87be-ec824dffdd99

Device Description

RPLCMT SI DAM FOR AR-1802 & AR-6510

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: 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
62456	Arthroscopic access cannula seal, single-use	A small, sterile device intended to create a seal between an arthroscopic access cannula (not included) and an appropriately sized arthroscopic instrument, to inhibit the leakage of flushing media (e.g., NaCl solution) during an arthroscopic procedure. It is intended to be fitted directly onto the proximal end of the cannula and is typically available in a variety of sizes appropriate for given sleeve/instrument diameters. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10888867007427	GS1
Unit of Use	00888867007420	GS1

Customer Contacts

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