ORTHOMED

Basic Information

• Brand Name: ORTHOMED
• Primary DI: B8033405040
• Version / Model: OM 34-0504
• Company Name: ORTHO-MED, INC.
• Labeler DUNS: 086618626
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-26
• Public Version: 2
• Public Version Date: 2024-01-24
• Public Version Status: Update
• Public Device Record Key: 88cc53b0-251c-40c2-8081-fa86db5cd76e

Device Description

BRAUN EPISIOTOMY SCISS. 8 1/2" ANG

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
33965	Episiotomy scissors, reusable	A hand-held, manual, obstetrical, surgical instrument intended to cut the outlet of the vagina in childbirth so as to facilitate the birth of the child (also known as perineotomy). It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and is available in various designs and sizes; the blades are typically angled, have different shapes, and may be serrated. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B8033405040	HIBCC

Customer Contacts

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