FDA.reportPublic FDA data

Body Armor® Stirrup Walker

Primary DI
10609271040134
Brand
Body Armor® Stirrup Walker
Company
DARCO INTERNATIONAL, INC.
Model
BPT3W
Catalog number
BPT3W
Device description
Tall, pneumatic, white (large)
Published
2023-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
10609271040134PackageGS14In Commercial Distribution
20609271040131PackageGS112In Commercial Distribution
00609271040137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060927104013410609271040134
2060927104013120609271040131
00609271040137006092710401376092710401370609271040137

GMDN Terms#

Term, Definition table
TermDefinition
Ankle/foot orthosisA prefabricated (non-customized) externally applied and wearable appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct orthopaedic deformities/injuries or to improve function of the ankle and/or foot through actions such as alignment, hinge-support, or dorsiflexion assistance. It may also be intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and help heal diabetic foot ulcers or postsurgical wounds, and may include patient adaptable plantar inserts. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184231298
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
0060927120013516'' DLX POST-OP KNEE IMMOB462-0012-30462-0012-302023-02-08
0060927120015916'' DLX POST-OP KNEE IMMOB462-0012-40462-0012-402023-02-08
0060927120017316'' DLX POST-OP KNEE IMMOB462-0012-50462-0012-502023-02-08
0060927120018016'' DLX POST-OP KNEE IMMOB462-0012-60462-0012-602023-02-08
0060927120019716'' DLX POST-OP KNEE IMMOB462-0012-70462-0012-702023-02-08
0060927120033320'' DLX POST-OP KNEE IMMOB462-0014-30462-0014-302023-02-08
0060927120035720'' DLX POST-OP KNEE IMMOB462-0014-40462-0014-402023-02-08
0060927120037120'' DLX POST-OP KNEE IMMOB462-0014-50462-0014-502023-02-08
0060927120038820'' DLX POST-OP KNEE IMMOB462-0014-60462-0014-602023-02-08
0060927120039520'' DLX POST-OP KNEE IMMOB462-0014-70462-0014-702023-02-08
0060927121050920'' DLX 3-PANEL KNEE IMMOB462-0025-10462-0025-102023-02-08
0060927121060820'' DLX 3-PANEL KNEE IMMOB462-0026-10462-0026-102023-02-08
0060927121080620'' DLX 3-PANEL KNEE IMMOB462-0028-10462-0028-102023-02-08
00609271610774"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (small)"E59410E594102023-02-08
00609271610781"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (medium)"E59411E594112023-02-08
00609271610798"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (large)"E59412E594122023-02-08
00609271610804"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (x-large)"E59413E594132023-02-08
00609271610811"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (small)"E59414E594142023-02-08
00609271610828"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (medium)"E59415E594152023-02-08
00609271610835"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (large)"E59416E594162023-02-08

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
00609271040106Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
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
20609271040148Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22