Integra® MicroFrance®

Basic Information

• Brand Name: Integra® MicroFrance®
• Primary DI: 10381780104575
• Version / Model: MCL-S31
• Catalog Number: MCL-S31
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2018-04-16
• Public Version: 4
• Public Version Date: 2023-05-16
• Public Version Status: Update
• Public Device Record Key: bde590cc-2d7a-4225-ac7b-fb799de6e480

Device Description

Integra® MicroFrance® Sataloff Disposable Vascular Knife

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JZY	KNIFE, LARYNGEAL	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12245	Ear knife	A hand-held manual surgical instrument intended to cut and dissect tissues of the ear during a surgical intervention. It is typically designed as a one-piece instrument with a sharp, single-edged, cutting blade at the distal end; this is normally quite small and may be of various shapes, and has a long slender shaft with a handle at the proximal end. It is normally made of high-grade stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780104575	GS1
Unit of Use	00381780104578	GS1

Customer Contacts

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