| Primary Device ID | 37290101427811 |
| NIH Device Record Key | 035c2fa9-8c1e-4366-add2-9871d5e7f661 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sion Biotext Medical Ltd. |
| Version Model Number | 1 |
| Catalog Number | 54W209-1206-912 |
| Company DUNS | 532775194 |
| Company Name | SION BIOTEXT MEDICAL LTD |
| Device Count | 100 |
| 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 | true |
| Manufacturing Date | true |
| 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 | 07290101427810 [Unit of Use] |
| GS1 | 37290101427811 [Primary] |
| KOY | Degreaser, Skin, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-27 |
| Device Publish Date | 2023-09-19 |
| 37290101427811 | Adhesive Remover is a uniquely formulated solution which ensures pain free removal of medical ad |
| 37290101427804 | Protective Barrier is a liquid film-forming dressing that, upon application to intact skin, form |
| 17290101427817 | Adhesive Remover is a uniquely formulated solution which ensures pain free removal of medical ad |
| 17290101427800 | Protective Barrier is a liquid film-forming dressing that, upon application to intact skin, form |
| 07290100663301 | The Lubricating Jelly is sterile, clear, colorless, non-sticky, non-greasy, non-staining, non-ir |
| 07290100663288 | The Lubricating Jelly is sterile, clear, colorless, non-sticky, non-greasy, non-staining, non-ir |