| Primary Device ID | 00859506006067 |
| NIH Device Record Key | 3a714433-1901-4a87-81af-b9de826f9c71 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Triton Sponge System |
| Version Model Number | GAUS-03 |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| 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 | 00859506006067 [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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-08-09 |
| 00859506006258 - TRITON | 2023-03-27 TRITON 3L CANISTER INSERT KIT |
| 00859506006005 - n/a | 2023-03-10 ACAIA PEARL SCALE 2.0 |
| 00859506006128 - Triton Canister System | 2018-07-26 MediVac Guardian 2L Scanning Label and Insert (PN 11032 and PN 11025) |
| 00859506006135 - Triton Canister System | 2018-07-26 MediVac CRD 3L v2 Scanning Label and Insert (PN 11032 and PN 11012) |
| 00859506006067 - Triton Sponge System | 2018-07-06 |
| 00859506006067 - Triton Sponge System | 2018-07-06 |
| 00859506006081 - Triton Sponge System-Calibration Card | 2018-07-06 |
| 00859506006098 - Triton Sponge System- NUI Sensor Bracket | 2018-07-06 NUI Sensor Bracket for Tryten Cart |
| 00859506006050 - Triton System (Sponge) | 2018-05-15 |