Identity
- Trade Name
- FemCath FDA UDI
- Generic Name
- Salpingographic catheter FDA UDI
- Device Name
- FemCath CBC-150 with VariLock and FemVue, 1 Pack FDA UDI
- Model / Reference
- CBC-150 FDA UDI
- Description
- FemCath CBC-150 with VariLock and FemVue, 1 Pack FDA UDI
Identifiers
- Catalog Number
- 04194 FDA UDI
- Primary DI / UDI-DI
- 00859500005080 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
- 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
Category: Salpingographic catheter
FemCath by Femasys Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Salpingographic catheter.
- Uterine Manipulator / Injector 4, 5mm — PURPLE SURGICAL INTERNATIONAL LIMITED · Class II
- Mckesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- Mckesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- FemCath — Femasys Inc. · Class II
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 9c60260b-3853-4249-8df0-ffa00d5fefdd 35 fields · synced Jun 8, 2026