Primary Device ID | 00859506006074 |
NIH Device Record Key | 62e86a71-56bc-42bc-b615-d68a74e873af |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Triton L&D System |
Version Model Number | GAUS-05 |
Catalog Number | GAUS-05 |
Company DUNS | 968757448 |
Company Name | GAUSS SURGICAL, INC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | 00859506006074 [Primary] |
JQP | Calculator/Data Processing Module, For Clinical Use |
MRL | Scale, Sponge, Surgical, Electrically-Powered |
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 | 2017-04-20 |
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 |
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 |