MicroFrance®

Basic Information

• Brand Name: MicroFrance®
• Primary DI: 10381780103899
• Version / Model: MCEN81-C
• Catalog Number: MCEN81-C
• Company Name: INTEGRA MICROFRANCE
• Labeler DUNS: 276593071
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-26
• Public Version: 2
• Public Version Date: 2023-05-15
• Public Version Status: Update
• Public Device Record Key: 3760ac2a-faec-4798-8345-e0ae8a0c0900

Device Description

MicroFrance® Sleeve for Comeg telescope 30 °, 4 mm diameter

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
KCB	TUBE, TONSIL SUCTION	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58098	Internally-anchored endoscopic retractor sleeve	A non-sterile, interchangeable, tubular device (sleeve) designed to be attached (screwed or snapped) to a dedicated applier and perform through a compatible endoscopic instrument (e.g., an access port) to insert an internally-anchored endoscopic retractor for hands-free retraction of a selected internal organ during a laparoscopic or thoracoscopic procedure. It is available in various diameters and lengths to accommodate various size internal retractors; after completion of the procedure it is used for extraction of the retractor. 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	10381780103899	GS1

Customer Contacts

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