Identity
- Trade Name
- SKYN FDA UDI
- Generic Name
- Basic male condom, synthetic polymer FDA UDI
- Device Name
- SKYN SELECTION 12CT (CONTAINS SKYN ORIGINAL, SKYN EXTRA STUDDED, SKYN ELITE EXTRA LUBE, SKYN ELITE) FDA UDI
- Model / Reference
- 0207 FDA UDI
- Description
- SKYN SELECTION 12CT (CONTAINS SKYN ORIGINAL, SKYN EXTRA STUDDED, SKYN ELITE EXTRA LUBE, SKYN ELITE) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00070907202074 FDA UDI
- 510(k) Number
- K160399 FDA UDI
- FDA Product Code
- MOL FDA UDI
- GMDN Term
- Basic male 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
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: Basic male condom, synthetic polymer
Skyn by Suretex Limited - Branch — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Basic male condom, synthetic polymer.
- Bioseal Inc. — BIOSEAL · Class I
- Durex Intense — RB Health (us) LLC · Class II
- Bioseal Inc. — BIOSEAL · Class I
- Trojan Raw - Non Latex — Church & Dwight Co., Inc. · Class II
- Lifestyles — LUNAMAX LLC · Class II
- SKYN — LIL DRUG STORE PRODUCTS, INC. · Class II
- LifeStyles SKYN Original 40 ct Bowl — PARADISE MARKETING SERVICES, A CALIFORNIA CORPORATION · Class II
- Durex Intense Ultra Lube — RB Health (us) LLC · Class II
Cleared under the same submission
K160399 also covers:
- Lifestyles — LUNAMAX LLC
- Lifestyles — LUNAMAX LLC
- Lifestyles — LUNAMAX LLC
- Lifestyles — LUNAMAX LLC
- LifeStyles SKYN Large 40 ct Bowl — PARADISE MARKETING SERVICES, A CALIFORNIA CORPORATION
- LifeStyles SKYN Original 40 ct Bowl — PARADISE MARKETING SERVICES, A CALIFORNIA CORPORATION
- LIFESTYLES — SURETEX LIMITED - BRANCH
- LIFESTYLES — SURETEX LIMITED - BRANCH
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
- Suretex Limited - Branch
Sources (1)
- FDA UDI 3b7cc9fd-fb1e-42cc-8d99-c9580e5c1d86 34 fields · synced May 30, 2026