ORTHOMED

Basic Information

• Brand Name: ORTHOMED
• Primary DI: B8033401420
• Version / Model: OM 34-0142
• Company Name: ORTHO-MED, INC.
• Labeler DUNS: 086618626
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-24
• Public Version: 3
• Public Version Date: 2024-01-19
• Public Version Status: Update
• Public Device Record Key: b5b3e7f1-cbdd-4c60-9eb8-044e11005dd1

Device Description

DEAVER SCISS. 5 1/2" STR. SS

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
HRR	Scissors, Orthopedic, Surgical	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38727	General-purpose surgical scissors, reusable	A hand-held manual surgical instrument designed to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed; some types may have blades that cross over to expose a sharp edge for slicing tissue like a scalpel. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B8033401420	HIBCC

Customer Contacts

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