Identity
- Trade Name
- TCV-FAC-21S(SBF)(23060) FDA UDI
- Generic Name
- Dental suction system FDA UDI
- Device Name
- This device is intended to remove droplets scattered from the oral cavity. This equipment is an electrical powered suction pumps as suction source. FDA UDI
- Model / Reference
- W131 FDA UDI
- Description
- This device is intended to remove droplets scattered from the oral cavity. This equipment is an electrical powered suction pumps as suction source. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04582539071264 FDA UDI
- FDA Product Code
- EBR FDA UDI
- GMDN Term
- Dental suction system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental suction system
Tcv-Fac-21s(sbf)(23060) by Tokyo Giken Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Tokyo Giken Inc.
Sources (1)
- FDA UDI 45ab3e92-d0d9-44f5-b63b-45f9a4209140 34 fields · synced May 31, 2026