| Primary Device ID | 19009607815008 |
| NIH Device Record Key | 52c24918-1d8d-40bd-84fb-e6c734e6efc9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ViVi PEEL-OFF HOOD |
| Version Model Number | 80500V |
| Catalog Number | 80500V |
| Company DUNS | 300188850 |
| Company Name | THI Total Healthcare Innovation GmbH |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-858-822-9433 |
| vincent.bates@thigmbh.at | |
| Phone | 1-858-822-9433 |
| vincent.bates@thigmbh.at | |
| Phone | 1-858-822-9433 |
| vincent.bates@thigmbh.at | |
| Phone | 1-858-822-9433 |
| vincent.bates@thigmbh.at | |
| Phone | 1-858-822-9433 |
| vincent.bates@thigmbh.at | |
| Phone | 1-858-822-9433 |
| vincent.bates@thigmbh.at | |
| Phone | 1-858-822-9433 |
| vincent.bates@thigmbh.at | |
| Phone | 1-858-822-9433 |
| vincent.bates@thigmbh.at | |
| Phone | 1-858-822-9433 |
| vincent.bates@thigmbh.at | |
| Phone | 1-858-822-9433 |
| vincent.bates@thigmbh.at | |
| Phone | 1-858-822-9433 |
| vincent.bates@thigmbh.at | |
| Phone | 1-858-822-9433 |
| vincent.bates@thigmbh.at | |
| Phone | 1-858-822-9433 |
| vincent.bates@thigmbh.at |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09009607815001 [Primary] |
| GS1 | 19009607815008 [Package] Contains: 09009607815001 Package: Carton box [20 Units] In Commercial Distribution |
| FXY | Hood, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-18 |
| Device Publish Date | 2025-06-10 |
| 19009607822204 - ViVi TOGA Premium Size XL-XXL | 2025-06-23 |
| 19009607822211 - ViVi TOGA Premium Size M-L | 2025-06-23 |
| 19009607822228 - ViVi TOGA Premium Size XXS-S | 2025-06-23 |
| 19009607832203 - ViVi TOGA Premium Size XL-XXL | 2025-06-23 |
| 19009607832210 - ViVi TOGA Premium Size M-L | 2025-06-23 |
| 19009607832227 - ViVi TOGA Premium Size XXS-S | 2025-06-23 |
| 19009607815008 - ViVi PEEL-OFF HOOD | 2025-06-18 |
| 19009607815008 - ViVi PEEL-OFF HOOD | 2025-06-18 |
| 09009607801004 - ViVi Helmet | 2023-11-20 |