Identity
- Trade Name
- Trustex FDA UDI
- Generic Name
- Basic male condom, Hevea-latex FDA UDI
- Device Name
- Trustex Non-Lubricated Colored Latex Condoms FDA UDI
- Model / Reference
- GS175 FDA UDI
- Description
- Trustex Non-Lubricated Colored Latex Condoms FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850002174694 FDA UDI
- 510(k) Number
- K081886 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
Trustex by Lunamax Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K081886 also covers:
- Atlas — LUNAMAX LLC
- ONE — LUNAMAX LLC
- ONE — LUNAMAX LLC
- ONE — LUNAMAX LLC
- Trustex — LUNAMAX LLC
- Trustex — LUNAMAX LLC
- DUREX Intense Sensation Condom — RB Health (us) LLC
- DUREX Intense Sensation Condom — RB Health (us) LLC
- DUREX Tropical Apple — RB Health (us) LLC
- DUREX Tropical Banana — RB Health (us) LLC
- DUREX Tropical Condoms — RB Health (us) LLC
- DUREX Tropical Condoms — RB Health (us) LLC
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
- Lunamax Llc
Sources (1)
- FDA UDI 4d5423f3-b7a9-4242-8665-3b4cc18465fb 34 fields · synced May 30, 2026