← Back to catalogue

MicroFrance®

FDA UDI

Class I (US FDA UDI)

by Integra Microfrance

Identity

Trade Name
MicroFrance® FDA UDI
Generic Name
Internally-anchored endoscopic retractor sleeve FDA UDI
Device Name
MicroFrance® Sleeve for Comeg telescope FDA UDI
Model / Reference
MCEN81-C FDA UDI
Description
MicroFrance® Sleeve for Comeg telescope FDA UDI

Identifiers

Catalog Number
MCEN81-C FDA UDI
Primary DI / UDI-DI
10381780539711 FDA UDI
FDA Product Code
KCB FDA UDI
GMDN Term
Internally-anchored endoscopic retractor sleeve FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4420 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Angle — 30 degree FDA UDI
Outer Diameter — 4 Millimeter FDA UDI

Category: Internally-anchored endoscopic retractor sleeve

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

Similar devices

Also classified as Internally-anchored endoscopic retractor sleeve.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Integra Microfrance

Sources (1)

  • FDA UDI c067eecc-7b6b-4a73-8ad8-e45bc670b403 36 fields · synced May 30, 2026