| Primary Device ID | 08809260470774 |
| NIH Device Record Key | 0c941fb6-03f9-432d-a449-9fe7e7a87327 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRAUS ENDO |
| Version Model Number | TRAUS ENDO #3 |
| Company DUNS | 688019566 |
| Company Name | Saeshin Precision Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809260470774 [Primary] |
| EKX | Handpiece, Direct Drive, Ac-Powered |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08809260470774]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-01-30 |
| Device Publish Date | 2020-01-22 |
| 08809260470774 | '10:1 TRAUS MCE10XX+TRAUS XEW10+ACL(B)-46EP |
| 08809260470767 | '16:1 TRAUS MCE10XX+TRAUS XEW10+ACL(B)-42EP |
| 08809260470743 | 20:1 TRAUS MCE10XX+TRAUS XEW10+ACL(B)-41EP |
| 08809260470262 | Angle Handpiece |
| 08809260470255 | Angle Handpiece |
| 08809260470248 | Charger |
| 08809260470231 | Control Box |