ORTHOMED

Basic Information

• Brand Name: ORTHOMED
• Primary DI: B8033510940
• Version / Model: OM 35-0194
• Company Name: ORTHO-MED, INC.
• Labeler DUNS: 086618626
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-19
• Public Version: 1
• Public Version Date: 2022-07-27
• Public Version Status: New
• Public Device Record Key: 33e7b24a-a5fa-4f97-94a9-4df4c438537c

Device Description

WIRE CUTT.SCISS. 4" CVD. SERR.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Manufacturing Date: No
• 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
HXZ	Cutter, Wire	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32885	Wire cutter	A heavy-duty, hand-held manual surgical instrument with sturdy handles and blade-like jaws designed to cut orthopaedic wires, cerclages, and small diameter pins or bolts. It has a scissors-like lever action with straight or curved handles and is made of high-grade stainless steel. It is available in various sizes and the cutting blades (typically short, strong and with obtuse cutting edges) at the working end are activated through a single or double-jointed pivot that transfers the necessary shearing/cutting force. Commonly known as wire cutting pliers the blades can have a side or front cutting action; some may have carbide inserts for greater durability. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B8033510940	HIBCC

Customer Contacts

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