SM1-03
SM1-03 (56328) is a Class I device made by Osada Electric Co., Ltd., listed in FDA GUDID since 7 Jun 2018 (UDI-DI 04580406869907), registry data as of 8 Jun 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04580406869907 | Date7 Jun 2018 | StatusListed |
Official records
- AccessGUDID record 04580406869907
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Generic name
- Remotely-driven surgical/dental system drive cable
- Model / Ref / Catalog
- SM1-03, 56328
- Primary DI / UDI-DI
- 04580406869907
- FDA product code
- EKX
- GMDN term
- Remotely-driven surgical/dental system drive cable
- Device class
- Class I
- Regulation number
- 872.4200
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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