Identity
- Trade Name
- CSR32 handpiece FDA UDI
- Generic Name
- Line-powered dental drilling/sawing system handpiece FDA UDI
- Model / Reference
- CSR32 FDA UDI
Identifiers
- Catalog Number
- 55367 FDA UDI
- Primary DI / UDI-DI
- 04582227436870 FDA UDI
- FDA Product Code
- EKX FDA UDI
- GMDN Term
- Line-powered dental drilling/sawing system handpiece 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
CSR32 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Osada Electric Co., Ltd.
Sources (1)
- FDA UDI c45c70a2-35da-4b81-83ef-1b9697a7d1b6 34 fields · synced May 30, 2026