FDA.reportPublic FDA data

Triton Canister System

Primary DI
10859506006132
Brand
Triton Canister System
Company
STRYKER CORPORATION
Model
FG-12011
Device description
Box of 50 PN 11035
Published
2018-06-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142801000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142801000Triton Canister SystemGauss Surgical, Inc.,2015-03-12PBZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859506006132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085950600613210859506006132

GMDN Terms#

Term, Definition table
TermDefinition
Blood loss estimation canister insert/labelA device in the form of a shaped plastic insert or an adhesive sticker intended to be placed in and/or on a surgical suction system canister to facilitate estimation of the quantity of external blood loss during a surgical procedure. It provides a uniform background and standardization of ambient lighting conditions to improve the quality of images taken by a device that runs blood loss estimation application software. The label may also be used as a device identifier. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
196548481
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327623338AXS LiftLIFT074095-01LIFT074095-012025-03-04
07613327623352AXS LiftLIFT074105-01LIFT074105-012025-03-04
07613327623376AXS LiftLIFT074110-01LIFT074110-012025-03-04
07613327623390AXS LiftLIFT074115-01LIFT074115-012025-03-04
07613327060027Precision Ideal Eyes05028190300502-819-0302016-09-23
07613327060072Precision Ideal Eyes05028230300502-823-0302016-09-23
07613327060102Precision Ideal Eyes05028231300502-823-1302016-09-23
07613327060119Precision Ideal Eyes05028270100502-827-0102016-09-23
07613327060126Precision Ideal Eyes05028230700502-823-0702016-09-23
07613327060140Precision Ideal Eyes05028270700502-827-0702016-09-23
07613327060157Precision Ideal Eyes05028271300502-827-1302016-09-23
07613327060164Precision Ideal Eyes05028270300502-827-0302016-09-23
07613327060232Precision Ideal Eyes05028230100502-823-0102016-09-23
07613327063875Precision Ideal Eyes, Speed-Lock05029270100502-927-0102016-09-23
07613327063882Precision Ideal Eyes, Speed-Lock05029270300502-927-0302016-09-23
07613327063899Precision Ideal Eyes, Speed-Lock05029270700502-927-0702016-09-23
07613327681741N/A48110005481100052025-09-03
07613327681727N/A48110004481100042025-09-03
07613327681758N/A48110006481100062025-09-03
37613327566162Neptune075020000007502000002024-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327622768TritonSTRYKER CORPORATIONPBZ2024-02-12
07613327622782N/ASTRYKER CORPORATIONPBZ2024-02-12
00859506006173TRITONSTRYKER CORPORATIONPBZ2022-12-23
00859506006258TRITONSTRYKER CORPORATIONPBZ2022-12-22
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