FDA.reportPublic FDA data

Prime Series

Primary DI
07613327613650
Brand
Prime Series
Company
STRYKER CORPORATION
Model
1125
Catalog number
1125-000-000C
Device description
1125-000-000C
Published
2024-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
INKStretcher, wheeled, powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INKStretcher, Wheeled, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327613650PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327613650076133276136507613327613650

GMDN Terms#

Term, Definition table
TermDefinition
Hospital stretcher, poweredA battery-powered mobile platform designed to transport a recumbent patient within a healthcare facility (e.g., to and from beds, chairs, treatment facilities, wheelchairs, and transportation vehicles). It typically includes a fixed, wheeled undercarriage, batteries, electric motor(s), and steering/operative controls. Some types, when fitted with a radiolucent surface, may be used for the acquisition of radiographic images.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078470558
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327681741N/A48110005481100052025-09-03
07613327681727N/A48110004481100042025-09-03
07613327681758N/A48110006481100062025-09-03
37613327566162Neptune075020000007502000002024-10-15
07613327504019NA5407-150-0005407-150-0002021-07-08
07613327504057NA5407-350-0005407-350-0002021-07-08
07613154495771NA62930000006293-000-0002015-09-24
07613154495801NA62970000006297-000-0002015-09-24
07613154495818NA62980000006298-000-0002015-09-24
07613154501410Electric System 6 Stryker Precision62990000006299-000-0002018-09-23
00850002250411ClariFixCFX-2002CFX-20022020-09-01
04546540517593ESSx52906012005290-601-2002016-09-24
07613327665109Sonopet iQ+55002600005500-260-0002026-10-14
07613327685114Sonopet iQ57000500005700-050-0002026-10-14
07613327665031Sonopet iQ+550026B0105500-26B-0102026-10-12
07613327665048Sonopet iQ+550026B0205500-26B-0202026-10-12
07613327665055Sonopet iQ+550026B1145500-26B-1142026-10-12
07613327665062Sonopet iQ+550026B3125500-26B-3122026-10-12
07613327687149Sonopet iQ+550026B3285500-26B-3282026-10-12
07613327662030ALPHAVENT3911-856-5473911-856-5472025-06-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08592654637432Sprint 400L I N E T spol. s r.o.INK2026-10-06
08592654637456Sprint 400L I N E T spol. s r.o.INK2026-10-06
08592654617656Sprint 200L I N E T spol. s r.o.INK2026-07-17
08592654618554Sprint 400L I N E T spol. s r.o.INK2026-07-17
08592654621530Sprint 400L I N E T spol. s r.o.INK2026-07-17
08592654601235Sprint 200L I N E T spol. s r.o.INK2026-05-11
08592654578445Sprint 400L I N E T spol. s r.o.INK2026-02-26
08592654556184Sprint 200L I N E T spol. s r.o.INK2025-12-22
08592654525883Sprint 200L I N E T spol. s r.o.INK2025-10-02
08592654542163Sprint 200L I N E T spol. s r.o.INK2025-10-02
08592654542811Sprint 200L I N E T spol. s r.o.INK2025-10-02
08592654542835Sprint 200L I N E T spol. s r.o.INK2025-10-02
07613327623437Prime SeriesSTRYKER CORPORATIONINK2024-05-06
07613327623468Prime SeriesSTRYKER CORPORATIONINK2024-05-06
08592654407868Sprint 200L I N E T spol. s r.o.INK2023-09-07
00861980000493BOUNDER Plus21ST CENTURY SCIENTIFIC, INC.INK2023-06-12
08592654389102Sprint 200L I N E T spol. s r.o.INK2023-04-14
08592654390894Sprint 200L I N E T spol. s r.o.INK2023-04-14
08592654387078Sprint 200L I N E T spol. s r.o.INK2023-01-27
08592654387870Sprint 200L I N E T spol. s r.o.INK2023-01-27
08592654356678Sprint 200L I N E T spol. s r.o.INK2022-11-10
08592654356685Sprint 200L I N E T spol. s r.o.INK2022-11-10
07613327175226NASTRYKER CORPORATIONINK2020-09-25
07613327175240NASTRYKER CORPORATIONINK2020-09-22
07613327175257NASTRYKER CORPORATIONINK2020-09-22
07613327175288NASTRYKER CORPORATIONINK2020-09-22
07613327175318NASTRYKER CORPORATIONINK2020-09-21
07613327283266HAVASUSTRYKER CORPORATIONINK2020-09-18
07613327282573HAVASUSTRYKER CORPORATIONINK2020-09-14
07613327504866NASTRYKER CORPORATIONINK2020-09-14