FDA.reportPublic FDA data

BOUNDER Plus

Primary DI
00861980000493
Brand
BOUNDER Plus
Company
21ST CENTURY SCIENTIFIC, INC.
Model
Power Gurney
Published
2023-06-12
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
00861980000493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861980000493008619800004938619800004930861980000493

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
099447922
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00861980000400BounderBOUNDER PLUS2017-07-05
00861980000417BounderBIG BOUNDER2017-07-05
00861980000486BOUNDER PlusManual Gurney2023-06-11
00861980000431BOUNDERBOUNDER 3002020-09-24
00861980000448BOUNDERBOUNDER PLUS 3002020-09-24
00861980000455BOUNDERBOUNDER 4502020-09-24
00861980000462BOUNDERBIG BOUNDER 6002020-09-24
00861980000479BOUNDERBIG BOUNDER 10002020-09-24
00861980000424BounderBOUNDER 300M2018-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
07613327261264NASTRYKER CORPORATIONINK2020-09-10
07613327261301NASTRYKER CORPORATIONINK2020-09-10
07613327261332NASTRYKER CORPORATIONINK2020-09-10