Identity
- Trade Name
- LIFESTYLES FDA UDI
- Generic Name
- Basic male condom, Hevea-latex FDA UDI
- Device Name
- MEGA RIDER 3CT FDA UDI
- Model / Reference
- 08859798100087 FDA UDI
- Description
- MEGA RIDER 3CT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08859798100087 FDA UDI
- 510(k) Number
- K001883 FDA UDI
- FDA Product Code
- HIS FDA UDI
- GMDN Term
- Basic male condom, Hevea-latex 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-latex
Lifestyles 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, Hevea-latex.
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Cleared under the same submission
K001883 also covers:
- Lifestyles — LIL DRUG STORE PRODUCTS, INC.
- Lifestyles — LUNAMAX LLC
- Lifestyles — LUNAMAX LLC
- LIFESTYLES — Mechanical Servants LLC
- LifeStyles King 40 ct Bowl — PARADISE MARKETING SERVICES, A CALIFORNIA CORPORATION
- 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
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 8c4485f5-7e0d-425a-949b-0c973307b6c7 35 fields · synced May 30, 2026