Identity
- Trade Name
- SH42 FDA UDI
- Generic Name
- Dental power tool system handpiece, remotely-driven FDA UDI
- Model / Reference
- SH42 FDA UDI
Identifiers
- Catalog Number
- 55741 FDA UDI
- Primary DI / UDI-DI
- 04580406861000 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
Sh42 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 ce165480-c55d-4f8e-900a-4f80e470c157 34 fields · synced May 30, 2026