Primary Device ID | 04580406869907 |
NIH Device Record Key | 2bdd386c-d80d-477c-a090-d4330e117107 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SM1-03 |
Version Model Number | SM1-03 |
Catalog Number | 56328 |
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 | 04580406869907 [Primary] |
EKX | HANDPIECE, DIRECT DRIVE, AC-POWERED |
Steralize Prior To Use | true |
Device Is Sterile | false |
[04580406869907]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-07-09 |
Device Publish Date | 2018-06-07 |
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 |