MicroFrance®

Basic Information

• Brand Name: MicroFrance®
• Primary DI: 10381780100317
• Version / Model: CP814-2
• Catalog Number: CP814-2
• Company Name: INTEGRA MICROFRANCE
• Labeler DUNS: 276593071
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-02
• Public Version: 4
• Public Version Date: 2023-05-15
• Public Version Status: Update
• Public Device Record Key: 88cbf4c0-0ad4-4d40-9c90-3f3811236cd2

Device Description

MicroFrance® Smooth plate for crushing press CP814-1

Device Characteristics

• Single Use: No
• 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: Yes
• 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
JYW	PRESS, VEIN	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60393	ENT cartilage cutter	A portable, manual surgical instrument intended to cut a harvested cartilage specimen (e.g., tragus-derived autograft) to an accurate predetermined thickness for patient implantation during an ear/nose/throat (ENT) procedure (e.g., middle ear surgery). It typically consists of an adjustable cutting assembly with a handle, base, and thickness dial used in conjunction with a removable ENT cartilage cutter blade. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780100317	GS1

Customer Contacts

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