Identity
- Trade Name
- CSR20L handpiece FDA UDI
- Generic Name
- Dental power tool system handpiece, remotely-driven FDA UDI
- Model / Reference
- CSR20L FDA UDI
Identifiers
- Catalog Number
- 55365 FDA UDI
- Primary DI / UDI-DI
- 04582227436863 FDA UDI
- FDA Product Code
- EKX FDA UDI
- GMDN Term
- Dental power tool system handpiece, remotely-driven FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Commercial Distribution
- Not 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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
CSR20L handpiece by Osada Electric 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
- Osada Electric Co., Ltd.
Sources (1)
- FDA UDI 6e3a3c5b-dfa2-445e-a700-63781945140c 34 fields · synced Jun 6, 2026