Arthrex®

Basic Information

• Brand Name: Arthrex®
• Primary DI: 00888867004368
• Version / Model: AR-1204AS-55
• Catalog Number: AR-1204AS-55
• Company Name: ARTHREX, INC.
• Labeler DUNS: 131747628
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-21
• Public Version: 4
• Public Version Date: 2020-07-24
• Public Version Status: Update
• Public Device Record Key: 2d0b47db-6ead-4573-8bc9-f4dee7baab2a

Device Description

FLIPCUTTER II, SHORT 5.5MM

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
HWE	INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64994	Reverse bone-resection orthopaedic reamer	An orthopaedic surgical instrument in the form of a shaft with a flip-out orthogonal cutting spike intended to resect bone (cut out part of the bone) as it is withdrawn to create a cylindrical recess for the acceptance of a prosthetic implant, typically a prosthetic ligament. It is introduced percutaneously through the bone shaft, and when in place the cutting spike is extended so that bone can be resected as the tip is rotated and withdrawn from the bone. It is made of metal and may be supplied with additional tools to assist with use (e.g., guide, depth guide). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00888867004368	GS1

Customer Contacts

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