Identity
- Trade Name
- Harmony Polyisoprene Single Sleeve FDA UDI
- Generic Name
- Female condom, synthetic polymer FDA UDI
- Model / Reference
- HA-101-INS FDA UDI
Identifiers
- Catalog Number
- REV C FDA UDI
- Primary DI / UDI-DI
- 00628347062774 FDA UDI
- 510(k) Number
- K203727 FDA UDI
- FDA Product Code
- MSC FDA UDI
- GMDN Term
- Female condom, synthetic polymer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.5300 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
No
FDA UDI
Category: Female condom, synthetic polymer
Harmony Polyisoprene Single Sleeve by Pamco Distributing Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Female condom, synthetic polymer.
- FC2 Female Condom® — Veru Inc. · Class II
- One and FC2 — GLOBAL PROTECTION CORP. · Class II
- FC2 — Veru Inc. · Class II
- 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 Latex Dam Retail Pack — Pamco Distributing Inc · Class II
- Harmony Latex Single Sleeve — Pamco Distributing Inc · Class II
Cleared under the same submission
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
- Pamco Distributing Inc
Sources (1)
- FDA UDI 57793a1f-07ca-46ea-b4d9-1a5e3bf61006 34 fields · synced May 29, 2026