Integra® MicroFrance®

FDA UDI

Class II (US FDA UDI)

by Integra Microfrance

Identity

Trade Name: Integra® MicroFrance® FDA UDI
Generic Name: Rectal suction biopsy system FDA UDI
Device Name: Integra® MicroFrance® Biopsy insert, 3 mm biopsy jaws and tube 5 mm diameter, 175 mm length for CEV504PS (Pk3) FDA UDI
Model / Reference: CEV504S3 FDA UDI
Description: Integra® MicroFrance® Biopsy insert, 3 mm biopsy jaws and tube 5 mm diameter, 175 mm length for CEV504PS (Pk3) FDA UDI

Identifiers

Catalog Number: CEV504S3 FDA UDI
Primary DI / UDI-DI: 10381780093596 FDA UDI
FDA Product Code: GCJ FDA UDI
GMDN Term: Rectal suction biopsy system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Rectal suction biopsy system

Integra® MicroFrance® by Integra Microfrance — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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rbi2 suction rectal biopsy system — Aus Systems Pty , Ltd. · Class II
rbi2 suction rectal biopsy system — Aus Systems Pty , Ltd. · Class II
Integra® MicroFrance® — Integra Microfrance · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Integra Microfrance

Sources (1)

FDA UDI 2033db09-9434-4ee3-9321-ce6c702a2534 36 fields · synced Jun 8, 2026