FDA.reportPublic FDA data

TRITON

Primary DI
00859506006173
Brand
TRITON
Company
STRYKER CORPORATION
Model
GAUS-6
Catalog number
GAUS-6
Device description
TRITON AI
Published
2022-12-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
PBZImage Processing Device For Estimation Of External Blood Loss

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PBZImage Processing Device For Estimation Of External Blood LossGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859506006173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859506006173008595060061738595060061730859506006173

GMDN Terms#

Term, Definition table
TermDefinition
Blood loss estimation application softwareAn application software program intended to be used for estimation of the quantity of external blood loss during a surgical procedure by analysis of images of blood-laden absorptive devices (e.g., swabs) and suction canisters. It is intended to run on an off-the-shelf or dedicated portable computerized device (e.g., smartphone, tablet, laptop) which may require an Internet connection. It does not store any patient demographic or clinical data. It typically includes upgrades to the software.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
196548481
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327170559VertaPlex HV04066220150406-622-0152016-09-23
07613327358308iVAS8080108000808-010-8002019-01-11
00850024195134MOLLIMS-00009MM10122022-06-27
04546540434371PCD SpinePlex05055820000505-582-0002015-09-24
04546540434388PCD SpinePlex05055830000505-583-0002015-09-24
04546540434395PCD SpinePlex05055850000505-585-0002015-09-24
04546540434401PCD SpinePlex05055860000505-586-0002015-09-24
04546540434418PCD05055870000505-587-0002015-09-24
04546540434425PCD05055890000505-589-0002015-09-24
07613327639032Broadway SystemBRW8E100D-3PK01BRW8E100D-3PK012025-03-12
07613327639049Broadway SystemBRW8E105D-3PK01BRW8E105D-3PK012025-03-12
07613327623338AXS LiftLIFT074095-01LIFT074095-012025-03-04
07613327623352AXS LiftLIFT074105-01LIFT074105-012025-03-04
07613327623376AXS LiftLIFT074110-01LIFT074110-012025-03-04
07613327623390AXS LiftLIFT074115-01LIFT074115-012025-03-04
07613327624069EchoECHO100100-01ECHO100100-012025-01-24
07613327624083EchoECHO100105-01ECHO100105-012025-01-24
07613327624106Broadway 8BRW084132-01BRW084132-012025-01-24
07613327561210Stroke Fast PackAXS2PK07404601AXS2PK074046012023-07-14
07613327561227Stroke Fast PackAXS2PK07104601AXS2PK071046012023-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327622768TritonSTRYKER CORPORATIONPBZ2024-02-12
07613327622782N/ASTRYKER CORPORATIONPBZ2024-02-12
00859506006258TRITONSTRYKER CORPORATIONPBZ2022-12-22
10859506006132Triton Canister SystemSTRYKER CORPORATIONPBZ2018-06-25
00859506006128TRITONSTRYKER CORPORATIONPBZ2018-06-25
00859506006135Triton Canister SystemSTRYKER CORPORATIONPBZ2018-06-25
10859506006101Triton Canister SystemSTRYKER CORPORATIONPBZ2018-02-16
00859506006104Triton Canister SystemSTRYKER CORPORATIONPBZ2018-02-16
10859506006095Triton Sponge- NUI Sensor bracketSTRYKER CORPORATIONPBZ2017-08-09
00859506006067TRITONSTRYKER CORPORATIONPBZ2017-08-09
00859506006081TRITONSTRYKER CORPORATIONPBZ2017-08-09
00859506006098Triton Sponge System- NUI Sensor BracketSTRYKER CORPORATIONPBZ2017-08-09
10859506006019Triton Canister SystemSTRYKER CORPORATIONPBZ2016-10-05
10859506006033Triton Canister SystemSTRYKER CORPORATIONPBZ2016-10-05
10859506006040Triton Canister SystemSTRYKER CORPORATIONPBZ2016-10-05
00859506006012Triton Canister SystemSTRYKER CORPORATIONPBZ2016-10-05
00859506006029TRITONSTRYKER CORPORATIONPBZ2016-10-05
00859506006036Triton Canister SystemSTRYKER CORPORATIONPBZ2016-10-05
00859506006043Triton Canister SystemSTRYKER CORPORATIONPBZ2016-10-05
00859506006050Triton System (Sponge)STRYKER CORPORATIONPBZ2016-10-05