Arthrex®

Basic Information

• Brand Name: Arthrex®
• Primary DI: 00888867040397
• Version / Model: AR-6569
• Catalog Number: AR-6569
• Company Name: ARTHREX, INC.
• Labeler DUNS: 131747628
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-04
• Public Version: 2
• Public Version Date: 2019-05-01
• Public Version Status: Update
• Public Device Record Key: 2f3646b1-b2d8-402e-9545-2c6d65f2cfeb

Device Description

EXPANULA WITH NO-SQUIRT CAP

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
NBH	Accessories, arthroscopic	Orthopedic	888.1100	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
Package	10888867040394	GS1	Box	5	In Commercial Distribution
Primary	00888867040397	GS1

Customer Contacts

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