FDA.reportPublic FDA data

NA

Primary DI
07613327175226
Brand
NA
Company
STRYKER CORPORATION
Model
0785-045-010
Catalog number
0785-045-010
Device description
Restraint Strap
Published
2020-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FPOSTRETCHER, WHEELED
INKStretcher, wheeled, powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPOStretcher, WheeledGeneral Hospital2
INKStretcher, Wheeled, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327175226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327175226076133271752267613327175226

GMDN Terms#

Term, Definition table
TermDefinition
Limb/torso/head restraint, reusableA non-rigid device, typically a strap(s) or band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078470558
Device count
1
Premarket exempt
true
Kit
true
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
08592654611951Sprint 100L I N E T spol. s r.o.FPO2026-07-17
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
0019079000638935X PROFLEXXFERNO-WASHINGTON, INC.FPO2026-03-24
00190790006570POWER F2FERNO-WASHINGTON, INC.FPO2026-03-24
00190790006600POWER X2FERNO-WASHINGTON, INC.FPO2026-03-24
G782MPC1000Prone CartElectro-Connect, Inc.FPO2026-03-19
08592654578445Sprint 400L I N E T spol. s r.o.INK2026-02-26
00887761005419Dynamo Series StretcherHILL-ROM, INC.FPO2026-02-19
00887761005457Side rail PadHILL-ROM, INC.FPO2026-02-19
00850073470091Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.FPO2026-01-27
08592654554524Sprint 100L I N E T spol. s r.o.FPO2026-01-07
08592654556184Sprint 200L I N E T spol. s r.o.INK2025-12-22
00841027102755Pedigo Products, Inc. PEDIGO PRODUCTS, INC.FPO2025-11-26
00841027102762Pedigo Products, Inc. PEDIGO PRODUCTS, INC.FPO2025-11-26
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
00850073470084Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.FPO2025-10-02
00190790003210POWER X2FERNO-WASHINGTON, INC.FPO2025-09-10
00817492013223NOA Medical IndustriesHoffmann NOA Medical Industries, LLCFPO2025-06-19
M3685B800STPD1HaustedGF HEALTH PRODUCTS, INC.FPO2025-06-11
M3685B800ST1HaustedGF HEALTH PRODUCTS, INC.FPO2025-06-11
00850073470015Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.FPO2025-04-23
00850073470022Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.FPO2025-04-23
00850073470039Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.FPO2025-04-23
00850073470046Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.FPO2025-04-23