Identity
- Trade Name
- Sustain Natural Extra Large Ribs and Dots. FDA UDI
- Generic Name
- Basic male condom, Hevea-latex FDA UDI
- Device Name
- The Sustain Natural Extra large Ribs and Dots is made of natural rubber latex. It is a bulbous teat ended, fully textured, transparent male condom. it meets the requirements as specified in ASTM D3492 standard for rubber latex contraceptives (Male Condoms). The Sustain Natural Extra large Ribs and Dots 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
- Sustain Natural Extra Large Ribs and Dots FDA UDI
- Description
- The Sustain Natural Extra large Ribs and Dots is made of natural rubber latex. It is a bulbous teat ended, fully textured, transparent male condom. it meets the requirements as specified in ASTM D3492 standard for rubber latex contraceptives (Male Condoms). The Sustain Natural Extra large Ribs and Dots 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
- 08906007132084 FDA UDI
- 510(k) Number
- K132490 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
Sustain Natural Extra Large Ribs and Dots. by Ttk Healthcare Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 3a2b9806-c4b1-458e-80d1-40d9662566e6 36 fields · synced Jun 8, 2026