FDA.reportPublic FDA data

Prime Series

Primary DI
07613327623437
Brand
Prime Series
Company
STRYKER CORPORATION
Model
1125
Catalog number
112505550001
Device description
112505550001
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
07613327623437PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327623437076133276234377613327623437

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
07613327651188VersiQuad0234112600234-112-6002026-07-22
07613252193791Neuroform3M003SNF325150M003SNF3251502015-05-29
07613252193845Neuroform3M003SNF335100M003SNF3351002015-05-29
07613252193913Neuroform3M003SNF345100M003SNF3451002015-05-29
07613154599127NA59200002045920-000-2042018-09-24
04546540434364SpinePlex04062020000406-202-0002016-06-30
07613154599097NA59200002015920-000-2012016-09-23
07613154599103NA59200002025920-000-2022018-09-24
07613154599110NA59200002035920-000-2032018-09-24
07613154599134NA59200002055920-000-2052018-09-24
07613154599141NA59200002065920-000-2062018-09-24
07613154599158NA59200002075920-000-2072018-09-24
07613154599165NA59200002085920-000-2082018-09-24
07613154599172NA59200002095920-000-2092018-09-24
07613154599189NA59200003015920-000-3012018-09-24
07613154599196NA59200003025920-000-3022018-09-24
07613154599202NA59200003035920-000-3032018-09-24
07613154599219NA59200003045920-000-3042018-09-24
07613154599226NA59200003055920-000-3052018-09-24
07613154599233NA59200003065920-000-3062018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07613327613650Prime 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
07613327261233NASTRYKER CORPORATIONINK2020-09-10
07613327261240NASTRYKER CORPORATIONINK2020-09-10