| Primary Device ID | 00854150007392 |
| NIH Device Record Key | 71a79ce0-eb64-489d-8129-7c3f51b7c357 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Specialty Anterior Hip Drape |
| Version Model Number | ORI-SDL-DAHIP |
| Catalog Number | ORI-SDL-DAHIP |
| Company DUNS | 080246656 |
| Company Name | Operating Room Innovations, Inc. |
| Device Count | 5 |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00854150007392 [Primary] |
| GS1 | 06975085708605 [Previous] |
| GS1 | 10854150007399 [Unit of Use] |
| PUI | Drape, Surgical, Exempt |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-09 |
| Device Publish Date | 2026-01-01 |
| 00854150007392 - Specialty Anterior Hip Drape | 2026-01-09ORI Specialty Anterior Hip Drape |
| 00854150007392 - Specialty Anterior Hip Drape | 2026-01-09 ORI Specialty Anterior Hip Drape |
| 00854150007408 - Specialty Lower Extremity Drape | 2026-01-09 ORI Specialty Lower Extremity Drape |
| 00854150007422 - Universal Upper Extremity Drape | 2026-01-09 ORI Universal Upper Extremity Drape |
| 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 |