Identity
- Trade Name
- Troj Variety Pack BareSkin FDA UDI
- Generic Name
- Dehydroepiandrosterone (DHEA) IVD, reagent FDA UDI
- Device Name
- For Contraception Plus STI Protection FDA UDI
- Model / Reference
- 00022600001577 FDA UDI
- Description
- For Contraception Plus STI Protection FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00022600001577 FDA UDI
- FDA Product Code
- HIS FDA UDI
- GMDN Term
- Dehydroepiandrosterone (DHEA) IVD, reagent 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
Yes
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: Dehydroepiandrosterone (DHEA) IVD, reagent
Troj Variety Pack BareSkin by Church & Dwight Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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K141256 also covers:
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- Trojan Bareskin Raw — Church & Dwight Co., Inc.
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- Trojan Bareskin Raw — Church & Dwight Co., Inc.
- Trojan Variety Pack BareSkin — Church & Dwight Co., Inc.
- Trojan Variety Pack BareSkin — 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 |
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Manufacturer
- Manufacturer
- Church & Dwight Co., Inc.
Sources (1)
- FDA UDI 3d0fe622-8e6a-4636-91c6-f5458eb88b2b 35 fields · synced Jun 9, 2026