| Primary Device ID | 00854150007101 |
| NIH Device Record Key | 80ad179d-503e-49b1-933c-4d0b8d18d105 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SF-3PXXL Solofit AAMI III SMS Gown Poly Reinforced XX-Large |
| Version Model Number | SF-3PXXL |
| Catalog Number | SF-3PXXL |
| Company DUNS | 080246656 |
| Company Name | OPERATING ROOM INNOVATIONS, 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 | 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 | 00854150007095 [Primary] |
| GS1 | 00854150007101 [Package] Contains: 00854150007095 Package: Case [24 Units] In Commercial Distribution |
| FYA | Gown, 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 | 2019-10-23 |
| Device Publish Date | 2017-03-02 |
| 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 |