Integra® MicroFrance®

Basic Information

• Brand Name: Integra® MicroFrance®
• Primary DI: 10381780093602
• Version / Model: CEV504S5
• Catalog Number: CEV504S5
• Company Name: INTEGRA MICROFRANCE
• Labeler DUNS: 276593071
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 6
• Public Version Date: 2023-04-25
• Public Version Status: Update
• Public Device Record Key: ad43e613-d163-4d86-bfcc-f33afa92519a

Device Description

Integra® MicroFrance® Biopsy insert, 5 mm biopsy jaws and tube 5 mm diameter, 175 mm length for CEV504PS (Pk3)

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: No
• 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
GCJ	Laparoscope, general & plastic surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58392	Rectal suction biopsy system	An assembly of disposable and reusable devices designed to obtain a submucosal tissue specimen from the rectum using suction [rectal suction biopsy (RSB)], typically for histopathological analysis [e.g., to help diagnose Hirschsprung's disease (HD)]. It typically consists of dedicated disposable capsules (e.g., plastic cylinder-shaped devices with a small hole at their closed end that contain a metallic cutting blade), suction tubing with negative pressure manometers, and a reusable handpiece.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780093602	GS1
Unit of Use	00381780093605	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K080257	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: No