FDA.reportPublic FDA data

N/A

Primary DI
07613327622782
Brand
N/A
Company
STRYKER CORPORATION
Model
0894000004
Catalog number
0894-000-004
Device description
SC+ AI Software
Published
2024-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
07613327622782PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327622782076133276227827613327622782

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

Contacts#

Phone, Email table
PhoneEmail
+0018002533210inst.stryker.cs@stryker.com

Regulatory Flags#

DUNS number
196548481
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327524475Optablate97000151009700-015-1002022-09-23
07613327638233Omnicurve10320150001032-015-0002024-09-03
00857037006075LATERALATSYS24LATSYS242020-01-14
00857037006037LATERALATSYS20LATSYS202020-01-08
07613327060058Precision Ideal Eyes05028190100502-819-0102016-09-23
07613327006223ARIA48755700487557002019-11-20
07613327006919ES2 SPINAL SYSTEM48280082482800822019-11-20
07613327006926ES2 SPINAL SYSTEM48280083482800832019-11-20
07613327006940ES2 SPINAL SYSTEM48280086482800862019-11-20
07613327006957ES2 SPINAL SYSTEM48280087482800872019-11-20
07613327007114ES2 SPINAL SYSTEM48280311482803112019-11-25
07613327007558XIA 348237078482370782019-11-25
07613327007565XIA 348237079482370792019-11-25
07613327067088ACCULIF8003578003572016-09-24
07613327067095ACCULIF8003478003472016-09-24
07613327114799XIA 4.5 EVOLUTION48138140481381402019-11-21
07613327114812XIA 4.5 EVOLUTION48138011R48138011R2019-11-20
07613327114843XIA 4.5 EVOLUTION48138011L48138011L2019-11-20
07613327114850XIA 4.5 EVOLUTION48138101481381012019-11-21
07613327114874ES2 SPINAL SYSTEM48280178482801782019-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327622768TritonSTRYKER CORPORATIONPBZ2024-02-12
00859506006173TRITONSTRYKER CORPORATIONPBZ2022-12-23
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