MicroFrance®

Basic Information

• Brand Name: MicroFrance®
• Primary DI: 10381780104650
• Version / Model: MCL-S4
• Catalog Number: MCL-S4
• Company Name: INTEGRA MICROFRANCE
• Labeler DUNS: 276593071
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2018-01-10
• Public Version: 3
• Public Version Date: 2023-05-15
• Public Version Status: Update
• Public Device Record Key: 60786e5e-6521-4316-be89-22a983589987

Device Description

MicroFrance® Sataloff straight injection needle (pk6) for MCL-S0 , 70 mm

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: 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
GDM	NEEDLE, ASPIRATION AND INJECTION, REUSABLE	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38824	General-purpose endoscopic needle, reusable	A flexible sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780104650	GS1
Unit of Use	00381780104653	GS1

Customer Contacts

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