| Primary Device ID | 09009607812000 |
| NIH Device Record Key | ea1af113-e80e-4307-a34f-a102ba23042e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ViVi Hood |
| Version Model Number | 80200V |
| Catalog Number | 80200V |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | 1-858-822-9433 |
| vincebates@ivysurgical.com | |
| Phone | 1-858-822-9433 |
| vincebates@ivysurgical.com | |
| Phone | 1-858-822-9433 |
| vincebates@ivysurgical.com | |
| Phone | 1-858-822-9433 |
| vincebates@ivysurgical.com | |
| Phone | 1-858-822-9433 |
| vincebates@ivysurgical.com | |
| Phone | 1-858-822-9433 |
| vincebates@ivysurgical.com | |
| Phone | 1-858-822-9433 |
| vincebates@ivysurgical.com | |
| Phone | 1-858-822-9433 |
| vincebates@ivysurgical.com | |
| Phone | 1-858-822-9433 |
| vincebates@ivysurgical.com | |
| Phone | 1-858-822-9433 |
| vincebates@ivysurgical.com | |
| Phone | 1-858-822-9433 |
| vincebates@ivysurgical.com | |
| Phone | 1-858-822-9433 |
| vincebates@ivysurgical.com | |
| Phone | 1-858-822-9433 |
| vincebates@ivysurgical.com | |
| Phone | 1-858-822-9433 |
| vincebates@ivysurgical.com | |
| Phone | 1-858-822-9433 |
| vincebates@ivysurgical.com | |
| Phone | 1-858-822-9433 |
| vincebates@ivysurgical.com | |
| Phone | 1-858-822-9433 |
| vincebates@ivysurgical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09009607812000 [Primary] |
| GS1 | 19009607812007 [Package] Package: [20 Units] In Commercial Distribution |
| FXY | Hood, Surgical |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[09009607812000]
Ethylene Oxide
[09009607812000]
Ethylene Oxide
[09009607812000]
Ethylene Oxide
[09009607812000]
Ethylene Oxide
[09009607812000]
Ethylene Oxide
[09009607812000]
Ethylene Oxide
[09009607812000]
Ethylene Oxide
[09009607812000]
Ethylene Oxide
[09009607812000]
Ethylene Oxide
[09009607812000]
Ethylene Oxide
[09009607812000]
Ethylene Oxide
[09009607812000]
Ethylene Oxide
[09009607812000]
Ethylene Oxide
[09009607812000]
Ethylene Oxide
[09009607812000]
Ethylene Oxide
[09009607812000]
Ethylene Oxide
[09009607812000]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-20 |
| Device Publish Date | 2023-11-10 |
| 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 |
| 09009607801004 - ViVi Helmet | 2023-11-20 |