Identity
- Trade Name
- SKYN FDA UDI
- Generic Name
- Basic male condom, synthetic polymer FDA UDI
- Device Name
- SKYN SELECTION 36CT (ORIGINAL, EXCITATION, ELITE EXTRA LUBE & ELITE) FDA UDI
- Model / Reference
- 0016 FDA UDI
- Description
- SKYN SELECTION 36CT (ORIGINAL, EXCITATION, ELITE EXTRA LUBE & ELITE) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00070907000168 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
Yes
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
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- Trojan Raw - Non Latex — Church & Dwight Co., Inc. · Class II
- Lifestyles — LUNAMAX LLC · Class II
- SKYN — LIL DRUG STORE PRODUCTS, INC. · Class II
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Cleared under the same submission
K171172 also covers:
- SKYN — LIL DRUG STORE PRODUCTS, INC.
- LIFESTYLES — SURETEX LIMITED - BRANCH
- SKYN — SURETEX LIMITED - BRANCH
- SKYN — SURETEX LIMITED - BRANCH
- SKYN — SURETEX LIMITED - BRANCH
- SKYN — SURETEX LIMITED - BRANCH
- SKYN — SURETEX LIMITED - BRANCH
- SKYN — SURETEX LIMITED - BRANCH
- SKYN — SURETEX LIMITED - BRANCH
- SKYN — SURETEX LIMITED - BRANCH
- SKYN — SURETEX LIMITED - BRANCH
- SKYN — SURETEX LIMITED - BRANCH
K182438 also covers:
- SKYN — SURETEX LIMITED - BRANCH
- SKYN — SURETEX LIMITED - BRANCH
- SKYN — SURETEX LIMITED - BRANCH
- SKYN — SURETEX LIMITED - BRANCH
- SKYN — SURETEX LIMITED - BRANCH
- SKYN — SURETEX LIMITED - BRANCH
- SKYN — SURETEX LIMITED - BRANCH
- SKYN — SURETEX LIMITED - BRANCH
- SKYN — SURETEX LIMITED - BRANCH
- SKYN — SURETEX LIMITED - BRANCH
- SKYN — SURETEX LIMITED - BRANCH
- SKYN — 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 4f887061-86e9-4ed1-907c-c9dc878e81e8 35 fields · synced May 30, 2026