Identity
- Trade Name
- CONTEMPO FDA UDI
- Generic Name
- Basic male condom, Hevea-latex FDA UDI
- Device Name
- CONTEMPO HOT RIDER FDA UDI
- Model / Reference
- 0068 FDA UDI
- Description
- CONTEMPO HOT RIDER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00070907200681 FDA UDI
- 510(k) Number
- K010371 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
Contempo by Suretex Limited - Branch — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Basic male condom, Hevea-latex.
- myONE N17/57H — GLOBAL PROTECTION CORP. · Class II
- SKORE Smooth Condoms - SKORE (Colors & Flavors) — Ttk Healthcare Limited · Class II
- ONE — GLOBAL PROTECTION CORP. · Class II
- ONE — GLOBAL PROTECTION CORP. · Class II
- ONE Vanish — GLOBAL PROTECTION CORP. · Class II
- ID Condoms — WESTRIDGE LABORATORIES INCORPORATED · Class II
- myONE Z21/60K — GLOBAL PROTECTION CORP. · Class II
- My One — GLOBAL PROTECTION CORP. · Class II
Cleared under the same submission
K010371 also covers:
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 c86d11f6-fdcd-4b15-9fa6-f37ac7d9ec1a 34 fields · synced May 30, 2026