Identity
- Trade Name
- Integra® MicroFrance® FDA UDI
- Generic Name
- Laparoscopic trocar blade, reusable FDA UDI
- Device Name
- Integra® MicroFrance® Smooth sleeve for CEV145A3 CEV145A5 CEV127PM, 5 mm diameter, 80 mm length FDA UDI
- Model / Reference
- CEV145B7 FDA UDI
- Description
- Integra® MicroFrance® Smooth sleeve for CEV145A3 CEV145A5 CEV127PM, 5 mm diameter, 80 mm length FDA UDI
Identifiers
- Catalog Number
- CEV145B7 FDA UDI
- Primary DI / UDI-DI
- 10381780092001 FDA UDI
- 510(k) Number
- K993653 FDA UDI
- FDA Product Code
- HET FDA UDI
- GMDN Term
- Laparoscopic trocar blade, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1720 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: Laparoscopic trocar blade, reusable
Integra® MicroFrance® by Integra Microfrance — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K993653 also covers:
- Integra® MicroFrance® — Integra Microfrance
- Integra® MicroFrance® — Integra Microfrance
- Integra® MicroFrance® — Integra Microfrance
- Integra® MicroFrance® — Integra Microfrance
- Integra® MicroFrance® — Integra Microfrance
- Integra® MicroFrance® — Integra Microfrance
- Integra® MicroFrance® — Integra Microfrance
- Integra® MicroFrance® — Integra Microfrance
- Integra® MicroFrance® — Integra Microfrance
- Integra® MicroFrance® — Integra Microfrance
- Integra® MicroFrance® — Integra Microfrance
- Integra® MicroFrance® — Integra Microfrance
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 37542834-df38-4228-8419-e73f86b69904 37 fields · synced May 31, 2026