FDA.reportPublic FDA data

Prime Series

Primary DI
07613327278286
Brand
Prime Series
Company
STRYKER CORPORATION
Model
1125
Catalog number
1125-000-000E
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
INKSTRETCHER, WHEELED, POWERED

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140095000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140095000PRIME ZOOM STRETCHERStryker Corporation2014-05-20INK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327278286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327278286076133272782867613327278286

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
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327631388N/A50275000005027-500-0002026-06-16
07613327631395N/A50275001005027-500-1002026-06-19
07613327632774N/A50275004005027-500-4002026-06-16
07613327651119VersiQuad0234112012234-112-0122026-07-16
07613327651126VersiQuad0234112611234-112-6112026-07-16
07613327651133VersiQuad0234112100234-112-1002026-07-16
07613327651140VersiQuad0234112608234-112-6082026-07-16
07613327651157VersiQuad0234112109234-112-1092026-07-16
07613327651164VersiQuad0234112500234-112-5002026-07-16
07613327651171VersiQuad0234112108234-112-1082026-07-16
07613327651195VersiQuad0234112607234-112-6072026-07-16
07613327651201VersiQuad0234112110234-112-1102026-07-16
07613327651218VersiQuad0234112609234-112-6092026-07-16
07613327651225VersiQuad0234112610234-112-6102026-07-16
07613327507935Stroke Fast PackSFP913140SFP9131402020-06-30
07613327507942Stroke Fast PackSFP913150SFP9131502020-06-30
07613327507959Stroke Fast PackSFP913160SFP9131602020-06-30
07613327507966Stroke Fast PackSFP913170SFP9131702020-06-30
07613327507973Stroke Fast PackSFP913180SFP9131802020-06-30
07613327507980Stroke Fast PackSFP913190SFP9131902020-06-30

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
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
07613327261233NASTRYKER CORPORATIONINK2020-09-10