Identity
- Trade Name
- Aowawo FDA UDI
- Generic Name
- Basic male condom, Hevea-latex FDA UDI
- Model / Reference
- 3 in 1 Male Latex Condoms, medium (53 ± 2mm) thickness: 0.065 ± 0.015mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06925634009011 FDA UDI
- 510(k) Number
- K222611 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Basic male condom, Hevea-latex
Aowawo by Suzhou Colourway New Material Co., Ltd. — 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
- Suzhou Colourway New Material Co., Ltd.
Sources (1)
- FDA UDI c46faeff-3d26-436b-8503-e5c0d26b9868 33 fields · synced May 30, 2026