Identity
- Trade Name
- m. Dior FDA UDI
- Generic Name
- Basic male condom, Hevea-latex FDA UDI
- Model / Reference
- 53±2mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00692563400122 FDA UDI
- 510(k) Number
- K083817 FDA UDI
- GMDN Term
- Basic male condom, Hevea-latex FDA UDI
Classification
- Commercial Distribution
- Not 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
Yes
FDA UDI
Combination Product
Yes
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
m. Dior by Suzhou Colourway New Material Co., Ltd. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K083817 also covers:
- GETANE — Suzhou Colourway New Material Co., Ltd.
- GETANE — Suzhou Colourway New Material Co., Ltd.
- GETANE — Suzhou Colourway New Material Co., Ltd.
- GETANE — Suzhou Colourway New Material Co., Ltd.
- GETANE — Suzhou Colourway New Material Co., Ltd.
- GETANE — Suzhou Colourway New Material Co., Ltd.
- GETANE — Suzhou Colourway New Material Co., Ltd.
- m. Dior — Suzhou Colourway New Material Co., Ltd.
- m.Dior.S Shock Shark Condoms — Suzhou Colourway New Material Co., Ltd.
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Suzhou Colourway New Material Co., Ltd.
Sources (1)
- FDA UDI 5f245cfd-abfd-4db7-9733-c9791cc77102 34 fields · synced Jun 8, 2026