Integra® MicroFrance®

Basic Information

• Brand Name: Integra® MicroFrance®
• Primary DI: 10381780490388
• Version / Model: MCEN148LP
• Catalog Number: MCEN148LP
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-14
• Public Version: 3
• Public Version Date: 2022-12-06
• Public Version Status: Update
• Public Device Record Key: d699c451-84b0-4b87-bfa8-4a9092275bd0

Device Description

LOANER Wormald Anterior Skull Base and Pituitary Instrument Kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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
OGR	Ear, nose, and throat surgical tray	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44065	Neurosurgical procedure kit, non-medicated, reusable	A collection of various neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical procedure. It does not contain pharmaceuticals. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780490388	GS1

Customer Contacts

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