Identity
- Trade Name
- kamasutra 12s Dotted condom FDA UDI
- Generic Name
- Basic male condom, Hevea-latex FDA UDI
- Device Name
- Pink coloured Dotted 53mm lubricated male latex condom , each pack contains 12 dotted lubricated condom - manfactured by Raymond Lifestyle Limited, Plot No G 35 & 36,MIDC,Waluj, Aurangabad, State Maharashtra, India, Pincode-431136 FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Pink coloured Dotted 53mm lubricated male latex condom , each pack contains 12 dotted lubricated condom - manfactured by Raymond Lifestyle Limited, Plot No G 35 & 36,MIDC,Waluj, Aurangabad, State Maharashtra, India, Pincode-431136 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08909014000414 FDA UDI
- 510(k) Number
- K931077 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
MR Safe FDA UDI
Category: Basic male condom, Hevea-latex
kamasutra 12s Dotted condom by R & A Logistics Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K931077 also covers:
- kamasutra 12s Chill Thril condom — R & A Logistics Inc
- kamasutra 12s Contoured condom — R & A Logistics Inc
- kamasutra 12s Fruit Flavoured condom — R & A Logistics Inc
- kamasutra 12s Ice Cream Flavoured condom — R & A Logistics Inc
- kamasutra 12s Intensity condom — R & A Logistics Inc
- kamasutra 12s Plain condom — R & A Logistics Inc
- kamasutra 12s Ribbed condom — R & A Logistics Inc
- kamasutra 12s Superthin condom — R & A Logistics Inc
- kamasutra 12s Ultrathin condom — R & A Logistics Inc
- kamasutra 12s Warm Intimacy condom — R & A Logistics Inc
- kamasutra 12s Wet N Wild condom — R & A Logistics Inc
- kamasutra 12s Xtra Large condom — R & A Logistics 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
- R & A Logistics Inc
Sources (1)
- FDA UDI 9690720c-1deb-4d50-8216-25869f80225b 36 fields · synced May 30, 2026