| Primary Device ID | 10840199500007 |
| NIH Device Record Key | 4f73986b-239d-44e4-9350-cfe64ba83888 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dilator Tube Set, Single Use, Sterile |
| Version Model Number | 7332-99D |
| Catalog Number | 7332-99D |
| Company DUNS | 007928633 |
| Company Name | KOROS U.S.A., INC. |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10840199500007 [Primary] |
| GXZ | Electrode, Needle |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-08 |
| Device Publish Date | 2022-01-31 |
| 10840199500007 | The dilators in the Dilator Tube Set can be used for both dilation and neuromonitoring. It cons |
| 10840199504487 | The dilators in the Dilator Tube Set can be used for both dilation and neuromonitoring. |
| 10840199504470 | The dilators in the Dilator Tube Set can be used for both dilation and neuromonitoring. |
| 10840199504463 | The dilators in the Dilator Tube Set can be used for both dilation and neuromonitoring. |