FDA.reportPublic FDA data

Body Armor® Stirrup Walker

Primary DI
00609271040106
Brand
Body Armor® Stirrup Walker
Company
DARCO INTERNATIONAL, INC.
Model
BPT0W
Catalog number
BPT0W
Device description
Tall, pneumatic, white (x-small)
Published
2023-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FZFSPLINT, EXTREMITY, INFLATABLE, EXTERNAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZFSplint, Extremity, Inflatable, ExternalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10609271040103PackageGS14In Commercial Distribution
20609271040100PackageGS112In Commercial Distribution
00609271040106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060927104010310609271040103
2060927104010020609271040100
00609271040106006092710401066092710401060609271040106

Regulatory Flags#

DUNS number
184231298
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00609271999336Aircore™ Offloading InsoleACI02026-07-20
00609271999343Aircore™ Offloading InsoleACI12026-07-20
00609271999374Aircore™ Offloading InsoleACI42026-07-20
00609271999381Aircore™ Offloading InsoleACI52026-07-20
00609271999473Aircore™ Offloading InsoleACI22026-07-20
00609271999480Aircore™ Offloading InsoleACI32026-07-20
00609271989603Aircore™ Offloading InsoleACIP0602026-01-07
00609271989610Aircore™ Offloading InsoleACIP0702026-01-07
00609271989627Aircore™ Offloading InsoleACIP0752026-01-07
00609271989634Aircore™ Offloading InsoleACIP0802026-01-07
00609271989658Aircore™ Offloading InsoleACIP0902026-01-07
00609271989665Aircore™ Offloading InsoleACIP0952026-01-07
00609271989672Aircore™ Offloading InsoleACIP1002026-01-07
00609271989689Aircore™ Offloading InsoleACIP1052026-01-07
00609271989696Aircore™ Offloading InsoleACIP1102026-01-07
00609271989702Aircore™ Offloading InsoleACIP1152026-01-07
00609271989719Aircore™ Offloading InsoleACIP1202026-01-07
00609271989726Aircore™ Offloading InsoleACIP1252026-01-07
00609271989733Aircore™ Offloading InsoleACIP1302026-01-07
00609271989740Aircore™ Offloading InsoleACIP1352026-01-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011549505SafeSplintAPARATA MEDICAL, LLCFZF2025-09-24
04251853902850Body Armor® PFA Walker LinerDarco (Europe) GmbHFZF2025-04-15
04251853902867Body Armor® PFA Walker LinerDarco (Europe) GmbHFZF2025-04-15
24251853902854Body Armor® PFA Walker LinerDarco (Europe) GmbHFZF2025-04-15
24251853902861Body Armor® PFA Walker LinerDarco (Europe) GmbHFZF2025-04-15
04251853902874Body Armor® PFA Walker LinerDarco (Europe) GmbHFZF2025-04-15
00609271040113Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
00609271040120Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
00609271040137Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
00609271040144Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
00609271040151Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
00609271040168Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
00609271040175Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
00609271040182Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
00609271040199Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
00609271040304Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
00609271040311Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
00609271040328Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
00609271040335Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
00609271040342Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
00609271040359Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
00609271040366Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
00609271040373Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
00609271040380Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
00609271040397Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
20609271040100Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
20609271040117Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
20609271040124Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
10609271040134Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
20609271040148Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22