| Primary Device ID | 00859506006012 |
| NIH Device Record Key | f1e24837-bf8a-4bfc-8bd8-b4ea48c17894 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Triton Canister System |
| Version Model Number | PN 11004 |
| Company DUNS | 968757448 |
| Company Name | GAUSS SURGICAL, INC |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00859506006012 [Primary] |
| PBZ | Image Processing Device For Estimation Of External Blood Loss |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-10-05 |
| 00859506006135 | MediVac CRD 3L v2 Scanning Label and Insert (PN 11032 and PN 11012) |
| 00859506006128 | MediVac Guardian 2L Scanning Label and Insert (PN 11032 and PN 11025) |
| 00859506006104 | Medivac Guardian 3L v2 Scanning Label and Insert (PN 11032 and PN 11001) |
| 00859506006043 | MediVac CRD 2L Scanning label and Insert (PN 11000 and PN 11025) |
| 00859506006036 | MediVac CRD 3L Scanning label and Insert (PN 11000 and PN 11012) |
| 00859506006029 | GAUS-02 |
| 00859506006012 | PN 11004 |