Identity
- Trade Name
- Integra® MicroFrance® FDA UDI
- Generic Name
- Externally-anchored laparoscopic retractor FDA UDI
- Device Name
- Integra® MicroFrance® Articulated wire pass, 5 mm diameter WL 335 mm FDA UDI
- Model / Reference
- CEV438B FDA UDI
- Description
- Integra® MicroFrance® Articulated wire pass, 5 mm diameter WL 335 mm FDA UDI
Identifiers
- Catalog Number
- CEV438B FDA UDI
- Primary DI / UDI-DI
- 10381780093220 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Externally-anchored laparoscopic retractor 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Externally-anchored laparoscopic retractor
Integra® MicroFrance® by Integra Microfrance — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Externally-anchored laparoscopic retractor.
- Mediflex Laparoscopic Instruments - Needle Holders — FLEXBAR MACHINE CORP. · Class I
- Mediflex Lapro-Flex Laproscopic Instruments — FLEXBAR MACHINE CORP. · Class I
- Mediflex Laparoscopic Instruments - Needle Holders — FLEXBAR MACHINE CORP. · Class I
- Mediflex Laparoscopic Instruments - Needle Holders — FLEXBAR MACHINE CORP. · Class I
- Mediflex Laparoscopic Instruments - Needle Holders — FLEXBAR MACHINE CORP. · Class I
- Holders and Positioners - Nathanson Hooks — FLEXBAR MACHINE CORP. · Class I
- Holders and Positioners - Nathanson Hooks — FLEXBAR MACHINE CORP. · Class I
- Mediflex Laparoscopic Instruments - Esophageal Dissector/Retractor — FLEXBAR MACHINE CORP. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Integra Microfrance
Sources (1)
- FDA UDI c45bbc82-30db-4554-98b8-560960dfe35a 36 fields · synced May 30, 2026