FDA.reportPublic FDA data

n/a

Primary DI
00859506006005
Brand
n/a
Company
STRYKER CORPORATION
Model
0894-001-015
Catalog number
0894-001-015
Device description
ACAIA PEARL SCALE 2.0
Published
2023-03-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
MRLScale, Sponge, Surgical, Electrically-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRLScale, Sponge, Surgical, Electrically-PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859506006005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859506006005008595060060058595060060050859506006005

GMDN Terms#

Term, Definition table
TermDefinition
Blood weighing scaleA mains electricity (AC-powered), electronic device specially designed to provide the precise weight of blood.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
196548481
Device count
1
Premarket exempt
true
Serial number
true

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
10197344161997MEDLINEMEDLINE INDUSTRIES, INC.MRL2025-10-17
07613327622775TritonSTRYKER CORPORATIONMRL2024-02-09
00809161317404DetectoCARDINAL SCALE MANUFACTURING COMPANYMRL2019-09-18
00859506006074TRITON STRYKER CORPORATIONMRL2017-04-20