GAUSS SURGICAL, INC

Address:334 State Street,Los Altos,CA,94022,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Image Processing Device For Estimation Of External Blood Loss (PBZ) (9) Scale, Sponge, Surgical, Electrically-Powered (MRL) (1)

Premarket Exempt

No Yes

Clear

Triton Canister System - 00859506006012 Catalog Number :

Device Class : 2

Duns Number: 968757448

Premarket Exempt : No

Product Code : PBZ

Prescription Use : Yes

Device Count : 1

Triton Canister System - 00859506006029 Catalog Number :

Device Class : 2

Duns Number: 968757448

Premarket Exempt : No

Product Code : PBZ

Prescription Use : Yes

Device Count : 1

Triton Canister System - 00859506006036 Catalog Number :

Device Description : MediVac CRD 3L Scanning label and Insert (PN 11000 and PN 11012)

Device Class : 2

Duns Number: 968757448

Premarket Exempt : No

Product Code : PBZ

Prescription Use : Yes

Device Count : 1

Triton Canister System - 00859506006043 Catalog Number :

Device Description : MediVac CRD 2L Scanning label and Insert (PN 11000 and PN 11025)

Device Class : 2

Duns Number: 968757448

Premarket Exempt : No

Product Code : PBZ

Prescription Use : Yes

Device Count : 1

Triton System (Sponge) - 00859506006050 Catalog Number :

Device Class : 2

Duns Number: 968757448

Premarket Exempt : No

Product Code : PBZ

Prescription Use : Yes

Device Count : 1

Triton Sponge System - 00859506006067 Catalog Number :

Device Class : 2

Duns Number: 968757448

Premarket Exempt : No

Product Code : PBZ

Prescription Use : Yes

Device Count : 1

Triton L&D System - 00859506006074 Catalog Number : GAUS-05

Device Description : Triton L&D System

Device Class : 1

Duns Number: 968757448

Premarket Exempt : Yes

Product Code : MRL

Prescription Use : Yes

Device Count : 1

Triton Sponge System-Calibration Card - 00859506006081 Catalog Number : PN 11207

Device Class : 2

Duns Number: 968757448

Premarket Exempt : No

Product Code : PBZ

Prescription Use : Yes

Device Count : 1

Triton Sponge System- NUI Sensor Bracket - 00859506006098 Catalog Number :

Device Description : NUI Sensor Bracket for Tryten Cart

Device Class : 2

Duns Number: 968757448

Premarket Exempt : No

Product Code : PBZ

Prescription Use : Yes

Device Count : 1

Triton Canister System - 00859506006104 Catalog Number :

Device Description : Medivac Guardian 3L v2 Scanning Label and Insert (PN 11032 and PN 11001)

Device Class : 2

Duns Number: 968757448

Premarket Exempt : No

Product Code : PBZ

Prescription Use : Yes

Device Count : 1

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