Arthrex®

Basic Information

• Brand Name: Arthrex®
• Primary DI: 00888867306189
• Version / Model: ABS-1050
• Catalog Number: ABS-1050
• Company Name: ARTHREX, INC.
• Labeler DUNS: 131747628
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-07
• Public Version: 4
• Public Version Date: 2022-07-04
• Public Version Status: Update
• Public Device Record Key: 6f6249a9-6eab-460e-aa70-4d4ae82eec0e

Device Description

Autologous Tissue Collector

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
60942	Orthopaedic surgery tissue debris collector, reusable	A device intended to be fitted to an orthopaedic rotary cutting tool (e.g., reamer) to collect bone, cartilage, or adjacent soft tissue debris/fragments created through resection during orthopaedic surgery (e.g., hip resurfacing). It is typically in the form of a cup-shaped attachment intended to prevent particulate bone entering the surgical wound. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00888867306189	GS1

Customer Contacts

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