MicroFrance®

Basic Information

• Brand Name: MicroFrance®
• Primary DI: 10381780089421
• Version / Model: 7803SAT-3
• Company Name: INTEGRA MICROFRANCE
• Labeler DUNS: 276593071
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-02
• Public Version: 3
• Public Version Date: 2019-12-06
• Public Version Status: Update
• Public Device Record Key: 995bc3be-1ce9-432b-9bc7-e6a3fb3634cd
• Distribution End Date: 2019-09-26

Device Description

TONGUE DEPRESSOR 7803SAT-3 FOR MCL76

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
KBL	DEPRESSOR, METAL TONGUE, SURGICAL	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
14066	Tongue depressor, surgical	A hand-held surgical instrument designed to displace and maintain the tongue in a fixed position, usually by depressing it towards the floor of the mouth. It is typically a metallic (e.g., high-grade stainless steel) device either with a straight shape, or more frequently smoothly bent at its center (e.g., to a 90? arch). The proximal end is used as a handle, while the distal end (usually serrated and may include holes) is used to depress the tongue. The device is used in oral surgery (e.g., during tonsillectomy). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780089421	GS1

Customer Contacts

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