Identity
- Trade Name
- FC2 FDA UDI
- Generic Name
- Female condom, synthetic polymer FDA UDI
- Device Name
- FC2 Female Condom FDA UDI
- Model / Reference
- 121107 FDA UDI
- Description
- FC2 Female Condom FDA UDI
Identifiers
- Catalog Number
- 121107 FDA UDI
- Primary DI / UDI-DI
- 30861783000103 FDA UDI
- PMA Number
- P080002 FDA UDI
- FDA Product Code
- MBU FDA UDI
- GMDN Term
- Female condom, synthetic polymer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.5340 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 170 Millimeter FDA UDI
Category: Female condom, synthetic polymer
Fc2 by Veru Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Female condom, synthetic polymer.
- Harmony Polyisoprene Dam Retail Pack — Pamco Distributing Inc · Class II
- Harmony Latex Dam Bulk Box — Pamco Distributing Inc · Class II
- Harmony Polyisoprene Dams Bulk Box — Pamco Distributing Inc · Class II
- Harmony Polyisoprene Single Sleeve — Pamco Distributing Inc · Class II
- Harmony Latex Dam Retail Pack — Pamco Distributing Inc · Class II
- One and FC2 — GLOBAL PROTECTION CORP. · Class II
- Harmony Latex Single Sleeve — Pamco Distributing Inc · Class II
- FC2 Female Condom® — Veru Inc. · Class II
Cleared under the same submission
P080002 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Veru Inc.
Sources (1)
- FDA UDI fd5bdde7-7ee1-4922-829f-a1dc35f7533c 38 fields · synced May 30, 2026