| Primary Device ID | 00843511100483 |
| NIH Device Record Key | cb56f710-997b-48ef-8879-906ef2114fd0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Omnia Medical VBR |
| Version Model Number | 06-8V-CAD2 |
| Catalog Number | 06-8V-CAD2 |
| Company DUNS | 079467378 |
| Company Name | OMNIA MEDICAL, LLC |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00843511100483 [Primary] |
| MQP | Spinal Vertebral Body Replacement Device |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
[00843511100483]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2019-09-10 |
| Device Publish Date | 2018-02-05 |
| 08435111000502 | Omnia Medical VBR, Short Inserter |
| 08435111000403 | Omnia Medical VBR, Inserter |
| 08435111000519 | Omnia Medical VBR, 12mm Tamp |
| 00843511101244 | 77mm Omnia Medical VBR Trial |
| 00843511101237 | 75mm Omnia Medical VBR Trial |
| 00843511101220 | 73mm Omnia Medical VBR Trial |
| 00843511101213 | 71mm Omnia Medical VBR Trial |
| 00843511101206 | 69mm Omnia Medical VBR Trial |
| 00843511101190 | 67mm Omnia Medical VBR Trial |
| 00843511101183 | 65mm Omnia Medical VBR Trial |
| 00843511101176 | 63mm Omnia Medical VBR Trial |
| 00843511101169 | 61mm Omnia Medical VBR Trial |
| 00843511101152 | 59mm Omnia Medical VBR Trial |
| 00843511100926 | 13mm Omnia Medical VBR Trial |
| 00843511101145 | 57mm Omnia Medical VBR Trial |
| 00843511101138 | 55mm Omnia Medical VBR Trial |
| 00843511101121 | 53mm Omnia Medical VBR Trial |
| 00843511101114 | 51mm Omnia Medical VBR Trial |
| 00843511101107 | 49mm Omnia Medical VBR Trial |
| 00843511101091 | 47mm Omnia Medical VBR Trial |
| 00843511101084 | 45mm Omnia Medical VBR Trial |
| 00843511101077 | 43mm Omnia Medical VBR Trial |
| 00843511101060 | 41mm Omnia Medical VBR Trial |
| 00843511101053 | 39mm Omnia Medical VBR Trial |
| 00843511101046 | 37mm Omnia Medical VBR Trial |
| 00843511101039 | 35mm Omnia Medical VBR Trial |
| 00843511101022 | 33mm Omnia Medical VBR Trial |
| 00843511101015 | 31mm Omnia Medical VBR Trial |
| 00843511101008 | 29mm Omnia Medical VBR Trial |
| 00843511100995 | 27mm Omnia Medical VBR Trial |
| 00843511100988 | 25mm Omnia Medical VBR Trial |
| 00843511100971 | 23mm Omnia Medical VBR Trial |
| 00843511100964 | 21mm Omnia Medical VBR Trial |
| 00843511100957 | 19mm Omnia Medical VBR Trial |
| 00843511100940 | 17mm Omnia Medical VBR Trial |
| 00843511100933 | 15mm Omnia Medical VBR Trial |
| 00843511100513 | Omnia Medical VBR, 12mm Tamp |
| 00843511100506 | Omnia Medical VBR, Short Inserter |
| 00843511100490 | Omnia Medical VBR, Case |
| 00843511100483 | Omnia Medical VBR, 14mm Implant Caddy |
| 00843511100476 | Omnia Medical VBR, 12mm Implant Caddy |
| 00843511100469 | Omnia Medical VBR, Endplate Release Tool |
| 00843511100452 | Omnia Medical VBR, Mallet |
| 00843511100445 | Omnia Medical VBR, Calipers |
| 00843511100438 | Omnia Medical VBR, Tamp |
| 00843511100421 | Omnia Medical VBR, Graft Packing Block |
| 00843511100414 | Omnia Medical VBR, Trial |
| 00843511100407 | Omnia Medical VBR, Inserter |
| 00843511100391 | Omnia Medical VBR, 14mm X 14.5mm X 7.5 Deg End Cap |
| 00843511100384 | Omnia Medical VBR, 14mm X 14.5mm X 5 Deg End Cap |