Identity
- Trade Name
- Femcare FDA UDI
- Generic Name
- Laparoscopic access cannula, single-use FDA UDI
- Model / Reference
- FN-100-212 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14714127864973 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Laparoscopic access cannula, single-use 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
Yes
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Laparoscopic access cannula, single-use
This Femcare device is a single-use laparoscopic access cannula designed for percutaneous insertion into the abdominal wall during laparoscopy or thoracoscopy. With its unique design and features, it provides a reliable and efficient way to create an access port for various medical instruments. This device is intended for single-use implantation only.
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Authorization Coverage (1 country)
Regulatory Authorizations
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
- Unimax Medical Systems Inc.
Sources (1)
- FDA UDI 18db1b48-58b7-497e-8329-7e3e10b66efb 32 fields · synced Jul 10, 2026