FDA.reportPublic FDA data

Prime Series

Primary DI
07613327278293
Brand
Prime Series
Company
STRYKER CORPORATION
Model
1125
Catalog number
1125-000-030
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
07613327278293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327278293076133272782937613327278293

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
07613327548235Neptune07031460050703-146-0052026-08-07
07613154615513NA59200003095920-000-3092018-09-24
04546540155245NA02907402000290-740-2002016-09-23
07613327358292iVAS8080208000808-020-8002020-06-12
07613327625172Steri-Shield04248010000424-801-0002025-02-21
07613327625257Steri-Shield04247212000424-721-2002025-02-21
07613327625288Steri-Shield04247412000424-741-2002025-02-21
07613327625295Steri-Shield04248211000424-821-1002025-02-21
07613327625332Steri-Shield04248212000424-821-2002025-02-21
07613327625349Steri-Shield04248312000424-831-2002025-02-21
07613327625363Steri-Shield04248512000424-851-2002025-02-21
07613327625370Steri-Shield04249210000424-921-0002025-02-21
07613327625387Steri-Shield04249410000424-941-0002025-02-21
07613327625394Steri-Shield04249510000424-951-0002025-02-21
07613327625400Steri-Shield04249310000424-931-0002025-02-21
07613327625417Steri-Shield04249412000424-941-2002025-02-21
07613327625424Steri-Shield04249311000424-931-1002025-02-21
07613327625431Steri-Shield04249211000424-921-1002025-02-21
07613327625448Steri-Shield04249312000424-931-2002025-02-21
07613327625455Steri-Shield04249512000424-951-2002025-02-21

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