Identity
- Trade Name
- SKORE Smooth Condoms - SKORE (Colors & Flavors) FDA UDI
- Generic Name
- Basic male condom, Hevea-latex FDA UDI
- Device Name
- The SKORE Smooth Condoms - SKORE (Colors & Flavors) condom is made of natural rubber latex. It is straight walled, smooth, thin, teat ended, transparent, Vanilla flavored male condoms. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Smooth Condoms - SKORE (Colors & Flavors) natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases). FDA UDI
- Model / Reference
- SKORE Vanilla FDA UDI
- Description
- The SKORE Smooth Condoms - SKORE (Colors & Flavors) condom is made of natural rubber latex. It is straight walled, smooth, thin, teat ended, transparent, Vanilla flavored male condoms. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Smooth Condoms - SKORE (Colors & Flavors) natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08906007135313 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
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: Basic male condom, Hevea-latex
SKORE Smooth Condoms - SKORE (Colors & Flavors) by Ttk Healthcare Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Ttk Healthcare Limited
Sources (1)
- FDA UDI 1d9c260c-7724-4b23-aa35-91e702e0d24b 34 fields · synced Jun 8, 2026