Identity
- Trade Name
- SKYN FDA UDI
- Generic Name
- Sexual lubricant FDA UDI
- Device Name
- SKYN ELITE 12CT + 1 NATURALLY ENDLESS SACHET FDA UDI
- Model / Reference
- 0108 FDA UDI
- Description
- SKYN ELITE 12CT + 1 NATURALLY ENDLESS SACHET FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00070907001080 FDA UDI
- FDA Product Code
- NUC FDA UDIMOL FDA UDI
- GMDN Term
- Sexual lubricant 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: Sexual lubricantBasic 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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Also classified as Basic male condom, synthetic polymer.
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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
- LifeStyles SKYN Original 40 ct Bowl — PARADISE MARKETING SERVICES, A CALIFORNIA CORPORATION · 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
K221243 also covers:
- LIFESTYLES — SURETEX LIMITED - BRANCH
- LIFESTYLES — SURETEX LIMITED - BRANCH
- LIFESTYLES — SURETEX LIMITED - BRANCH
- 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
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
- Suretex Limited - Branch
Sources (1)
- FDA UDI 40811d4d-1a02-4fd8-a665-96a1b3658421 35 fields · synced Jun 8, 2026