Identity
- Trade Name
- Trojan Enz 40 ct Bowl FDA UDI
- Generic Name
- Basic male condom, Hevea-latex FDA UDI
- Model / Reference
- 813356000125 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00813356000125 FDA UDI
- 510(k) Number
- K901192 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
Trojan Enz 40 ct Bowl by Paradise Marketing Services, A California Corporation — 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
K901192 also covers:
- TROJAN 100CT BULK MIX — Church & Dwight Co., Inc.
- Trojan All The Feels Variety Pack — Church & Dwight Co., Inc.
- Trojan All The Feels Variety Pack — Church & Dwight Co., Inc.
- Trojan All the Feels Condom — Church & Dwight Co., Inc.
- Trojan Enz Condom — Church & Dwight Co., Inc.
- Trojan HotSpot Vibrating Ring and 1 Ultra Thin Condom — Church & Dwight Co., Inc.
- Trojan Variety Pack — Church & Dwight Co., Inc.
- Trojan Willa Thin Condom — Church & Dwight Co., Inc.
- Trojan™ ENZ™ Latex Lubricated Condoms — Church & Dwight Co., Inc.
- Trojan™ Pleasure Pack — Church & Dwight Co., Inc.
- Trojan™ Premium Latex Condoms ENZ™ Lubricated Condoms — Church & Dwight Co., Inc.
- Trojan™ Premium Latex Condoms ENZ™ Value Pack — Church & Dwight Co., Inc.
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
Sources (1)
- FDA UDI 6d329e26-9290-49bb-a702-dbe2cc9a3b4f 33 fields · synced Jun 6, 2026