Identity
- Trade Name
- FemCath FDA UDI
- Generic Name
- Salpingographic catheter FDA UDI
- Device Name
- FemCath, Cornual Balloon Catheter, CBC-100 with StopLock, 1 Pack (tray) FDA UDI
- Model / Reference
- CBC-100 FDA UDI
- Description
- FemCath, Cornual Balloon Catheter, CBC-100 with StopLock, 1 Pack (tray) FDA UDI
Identifiers
- Catalog Number
- 02827 FDA UDI
- Primary DI / UDI-DI
- 00859500005035 FDA UDI
- 510(k) Number
- K100662 FDA UDI
- FDA Product Code
- LKF FDA UDI
- GMDN Term
- Salpingographic catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
FemCath by Femasys Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K100662 also covers:
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
- Femasys Inc.
Sources (1)
- FDA UDI fbb80972-e25d-4582-a616-fe5b57e0d379 36 fields · synced Jun 8, 2026