Identity
- Trade Name
- COOSKIN FDA UDI
- Generic Name
- Water jet flosser FDA UDI
- Device Name
- Oral Irrigator FDA UDI
- Model / Reference
- C8-1 FDA UDI
- Description
- Oral Irrigator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06978123370109 FDA UDI
- FDA Product Code
- EFS FDA UDI
- GMDN Term
- Water jet flosser FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6510 FDA UDI
- 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Cooskin by Ningbo Cooskin Stationery Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Ningbo Cooskin Stationery Co., Ltd.
Sources (1)
- FDA UDI 47daeaa0-5fcb-4302-a31c-9816c083646e 34 fields · synced May 30, 2026