Arthrex®

Basic Information

• Brand Name: Arthrex®
• Primary DI: 00888867258112
• Version / Model: ABS-10062D
• Catalog Number: ABS-10062D
• Company Name: ARTHREX, INC.
• Labeler DUNS: 131747628
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-28
• Public Version: 9
• Public Version Date: 2020-07-23
• Public Version Status: Update
• Public Device Record Key: 0f6d7ea2-a6e0-4320-9249-d9f97e74aeff

Device Description

Angel System w/ Pwr Aspiration Kit wACDA

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• 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
ORG	Platelet and plasma separator for bone graft handling	Hematology	864.9245	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45815	Haemodialysis citrate anticoagulation solution	A citric acid (citrate) formulation introduced into the extracorporeal circuit of a dialysis system to inhibit the coagulation of blood, typically during continuous renal replacement therapy (CRRT) - physiological dialysis performed over a 24-hour period or longer. Citrate inhibits coagulation by binding with calcium and rendering calcium unavailable to the clotting cascade. When blood from the extracorporeal circuit is returned to the patient it mixes with central venous blood which contains calcium that has been continuously administered to the patient, and the anticoagulant effect is neutralized. It is typically supplied in a polyvinyl chloride (PVC) bag. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M150ABS10062D1	HIBCC
Primary	00888867258112	GS1

Customer Contacts

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