| Primary Device ID | 00854150007125 |
| NIH Device Record Key | f3a6d533-f5b2-4e3a-b5d7-e5f794b2b721 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DS-100 ORI Drop Stop Kit |
| Version Model Number | DS-100 |
| Catalog Number | DS-100 |
| Company DUNS | 080246656 |
| Company Name | OPERATING ROOM INNOVATIONS, INC. |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00854150007118 [Primary] |
| GS1 | 00854150007125 [Package] Contains: 00854150007118 Package: Case [40 Units] In Commercial Distribution |
| KKX | Drape, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-11-08 |
| Device Publish Date | 2017-03-02 |
| 26975424191642 - Operating Room Innovations, Inc | 2023-04-13 Shield Guards-Removable Peel Away, 2 per Pouch |
| 16975085709401 - ORI | 2023-04-12 HaloFit Large with Face Shield AAMI IV |
| 16975085709418 - ORI | 2023-04-12 HaloFit XXX-Large with Face Shield AAMI IV |
| 26975424191451 - ORI | 2023-04-12 Face Shield, Attached with Full Head Covering |
| 26975424191468 - ORI | 2023-04-12 ORI Drop Stop |
| 26975424191475 - ORI | 2023-04-12 Face Shield, Attached w. AAMI IV Head Covering |
| 26975085708333 - ORI | 2023-04-11 SmokeStop - Smoke Evacuation 20" Tubing |
| 26975085708524 - ORI | 2023-04-11 SterileBack Toga XL-EL w. Face Shield |