Arthrex®

Basic Information

• Brand Name: Arthrex®
• Primary DI: 00888867001930
• Version / Model: ABS-10026-15
• Catalog Number: ABS-10026-15
• Company Name: ARTHREX, INC.
• Labeler DUNS: 131747628
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-30
• Public Version: 6
• Public Version Date: 2020-01-23
• Public Version Status: Update
• Public Device Record Key: 881bddbc-09b5-466b-a399-eeb552d3195c

Device Description

SLEEVE FOR COUNTERWEIGHT ABS-10026

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
JQC	CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15682	Centrifuge bucket/tube holder	A cylindrical or bucket-like device designed as a removable component of a centrifuge rotor head intended to safely contain (hold) a laboratory test tube or centrifuge tube containing a sample/specimen while the centrifuge is being operated at high speeds. It is typically made of metal or a strong synthetic polymer, has one or multiple positions for holding the sample/specimen tubes, and is open at the proximal end for their insertion. A protective screw-top cap or lid may be included to contain the contents of one or more sample/specimen tubes in the event of breakage. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00888867001930	GS1

Customer Contacts

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