Identity
- Trade Name
- LIFESTYLES FDA UDI
- Generic Name
- Basic male condom, synthetic polymer FDA UDI
- Device Name
- LIFESTYLES SENSUAL COLLECTION 12CT- CONTAINS ULTRA SENSITIVE, ULTRA SENSITIVE PLATINUM AND SKYN ELITE FDA UDI
- Model / Reference
- 3122 FDA UDI
- Description
- LIFESTYLES SENSUAL COLLECTION 12CT- CONTAINS ULTRA SENSITIVE, ULTRA SENSITIVE PLATINUM AND SKYN ELITE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00070907231227 FDA UDI
- FDA Product Code
- HIS FDA UDIMOL 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
Yes
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, Hevea-latexBasic male condom, synthetic polymer
Lifestyles 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
- SKYN — SURETEX LIMITED - BRANCH
K163107 also covers:
- LIFESTYLES — SURETEX LIMITED - BRANCH
- LIFESTYLES — SURETEX LIMITED - BRANCH
- LIFESTYLES — SURETEX LIMITED - BRANCH
- LIFESTYLES — SURETEX LIMITED - BRANCH
- LIFESTYLES — SURETEX LIMITED - BRANCH
- LIFESTYLES — SURETEX LIMITED - BRANCH
- LIFESTYLES — SURETEX LIMITED - BRANCH
- LIFESTYLES — SURETEX LIMITED - BRANCH
- LIFESTYLES — SURETEX LIMITED - BRANCH
- LIFESTYLES — SURETEX LIMITED - BRANCH
- LIFESTYLES — SURETEX LIMITED - BRANCH
- LIFESTYLES — SURETEX LIMITED - BRANCH
K941258 also covers:
- Keypers — GLOBAL PROTECTION CORP.
- Keypers — GLOBAL PROTECTION CORP.
- Keypers — GLOBAL PROTECTION CORP.
- Keypers — GLOBAL PROTECTION CORP.
- Keypers — GLOBAL PROTECTION CORP.
- Keypers — GLOBAL PROTECTION CORP.
- Keypers — GLOBAL PROTECTION CORP.
- Keypers — GLOBAL PROTECTION CORP.
- Keypers — GLOBAL PROTECTION CORP.
- Keypers — GLOBAL PROTECTION CORP.
- Keypers — GLOBAL PROTECTION CORP.
- Keypers — GLOBAL PROTECTION CORP.
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 59dfdecf-a1c4-41cf-88b0-fef009ff9760 34 fields · synced May 30, 2026