| Primary Device ID | 04582227436887 |
| NIH Device Record Key | 792a9df9-06c6-4a4e-a6f5-8b19a5e1d7b7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SM2L motor |
| Version Model Number | SM2L |
| Catalog Number | 55368 |
| Company DUNS | 690713813 |
| Company Name | OSADA ELECTRIC CO.,LTD. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04582227436887 [Primary] |
| EKX | HANDPIECE, DIRECT DRIVE, AC-POWERED |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04582227436887]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-29 |
| 04582227353498 - ST45 | 2020-03-27 |
| 04580406860690 - ST38-90R | 2019-02-21 |
| 04580406860706 - ST38-90L | 2019-02-21 |
| 04580406860713 - ST38-90 | 2019-02-21 |
| 04580406860720 - AP set 7 | 2019-02-21 |
| 04580406860737 - AP point 1 | 2019-02-21 |
| 04580406860744 - AP point 2 | 2019-02-21 |
| 04580406860751 - AP point 3 | 2019-02-21 |