| Primary Device ID | 08056646507481 |
| NIH Device Record Key | 6fdd0774-60ba-4ca9-b8a9-b18782f673fd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Special Plus model gown (length 115 cm) size L |
| Version Model Number | 30.D2172.00 |
| Company DUNS | 447696675 |
| Company Name | OMNIA SRL |
| Device Count | 12 |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08056646507474 [Primary] |
| GS1 | 08056646507481 [Unit of Use] |
| OEA | Non-Surgical Isolation Gown |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-30 |
| Device Publish Date | 2023-06-22 |
| 08056646509966 - Irrigation Set | 2024-11-19 |
| 08056646509980 - Irrigation Set | 2024-11-19 |
| 08052141311400 - Irrigation line, Kavo | 2023-08-16 Sterilizable Hose Set S600 |
| 08052141311424 - Irrigation line, Kavo | 2023-08-16 Hose set for Kavo INTRASurg (10/pkg) |
| 08052141310014 - Transparent bag 67x75 cm with sliding ties for physiodispensers or for control u | 2023-07-06 Transparent bag 67x75 cm with sliding ties for physiodispensers or for control units |
| 08056646505739 - Omnicover | 2023-07-06 Round waterproof headrest cover Ø 22 cm with elastic Shell Cover |
| 08056646505890 - Universal seat cover and backrest cover Shell Cover | 2023-07-06 Universal seat cover and backrest cover Shell Cover |
| 08056646508563 - Transparent drape 40x50 cm with adhesive tape for physiodispensers or for contro | 2023-07-06 Transparent drape 40x50 cm with adhesive tape for physiodispensers or for control units |