Arthrex®

Basic Information

• Brand Name: Arthrex®
• Primary DI: 00888867286580
• Version / Model: ABS-10080
• Catalog Number: ABS-10080
• Company Name: ARTHREX, INC.
• Labeler DUNS: 131747628
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-30
• Public Version: 5
• Public Version Date: 2020-03-11
• Public Version Status: Update
• Public Device Record Key: 76a9f834-fabd-45ed-9857-9d4814cd8fe3

Device Description

Thrombinator™ System

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: 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
47155	Haematological concentrate system preparation kit, thrombin separation	A collection of sterile devices intended for use at the point-of-care for preparation of autologous thrombin (AT) from a blood specimen. The kit components, with the blood specimen, are directly placed in a dedicated centrifuge that separates the AT from the peripheral blood. The AT preparations, in combination with autologous plasma and concentrated platelets, can be applied to surgical wounds to help control minor bleeding, or mixed with bone graft materials to assist the healing and/or graft acceptance process. The kit may include sample drawing devices. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00888867286580	GS1

Customer Contacts

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