Arthrex®

Basic Information

• Brand Name: Arthrex®
• Primary DI: 00888867299566
• Version / Model: 1002.34A0
• Catalog Number: 1002.34A0
• Company Name: ARTHREX, INC.
• Labeler DUNS: 131747628
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-12
• Public Version: 2
• Public Version Date: 2021-06-28
• Public Version Status: Update
• Public Device Record Key: 91fc1bad-419c-44d4-8d86-3f215876e16c

Device Description

TRIMANO Fortis Knee Kit

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: 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
BWN	TABLE AND ATTACHMENTS, OPERATING-ROOM	General, Plastic Surgery	878.4950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48139	Orthopaedic knee/leg holder liner	A sterile pad/cover designed to be placed between a patient's leg and an orthopaedic knee/leg holder, cushioning the leg to reduce the risk of damage of the skin/muscles/nerves during an orthopaedic procedure (e.g., arthroscopy, arthroplasty). It is typically made of disposable plastic material (e.g., a foam) with an appropriate shape and size to fit the holder. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10888867299563	GS1	Box	6	Not in Commercial Distribution	2021-06-26
Primary	00888867299566	GS1

Customer Contacts

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