FDA.reportPublic FDA data

Body Armor® PFA Walker

Primary DI
04251853902829
Brand
Body Armor® PFA Walker
Company
Darco (Europe) GmbH
Model
BAPFA2
Catalog number
BAPFA2
Device description
Foot Stump Orthosis, Gray-Blue, M
Published
2025-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NOCSplint, Extremity, Non-Inflatable, External, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOCSplint, Extremity, Non-Inflatable, External, Non-SterileGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14251853902826PackageGS14In Commercial Distribution
24251853902823PackageGS112In Commercial Distribution
04251853902829PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1425185390282614251853902826
2425185390282324251853902823
04251853902829042518539028294251853902829

GMDN Terms#

Term, Definition table
TermDefinition
Inflatable extremity splint, reusableA sleeve intended to be placed around an arm or leg and inflated to immobilize and protect the limb following injury. It is typically used by emergency medical services (EMS) as a temporary measure in emergencies to stabilize the limb for transport to a hospital. This is a reusable device.

Regulatory Flags#

DUNS number
343551081
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00609271950238MECRON Knee Flexion L:400mm, OS:430mm, US:300mmOH400104OH4001042023-02-08
00609271950269MECRON Knee Flexion L:400mm, OS:480mm, US:350mmOH400204OH4002042023-02-08
00609271950290MECRON Knee Flexion L:400mm, OS:530mm, US:400mmOH400304OH4003042023-02-08
00609271950320MECRON Knee Flexion L:500mm, OS:440mm, US:230mmOH500104OH5001042023-02-08
00609271950351MECRON Knee Flexion L:500mm, OS:490mm, US:280mmOH500204OH5002042023-02-08
00609271950382MECRON Knee Flexion L:500mm, OS:540mm, US:330mmOH500304OH5003042023-02-08
00609271950412MECRON Knee Flexion L:500mm, OS:590mm, US:380mmOH500404OH5004042023-02-08
00609271950443MECRON Knee Flexion L:600mm, OS:450mm, US:220mmOH600104OH6001042023-02-08
00609271950474MECRON Knee Flexion L:600mm, OS:500mm, US:270mmOH600204OH6002042023-02-08
00609271950504MECRON Knee Flexion L:600mm, OS:550mm, US:320mmOH600304OH6003042023-02-08
00609271950535MECRON Knee Flexion L:600mm, OS:600mm, US:350mmOH600404OH6004042023-02-08
00609271950559MECRON Knee 3-partOH655124OH6551242023-02-08
00609271950573MECRON Knee 3-partOH655324OH6553242023-02-08
00609271950597MECRON Knee 3-partOH655524OH6555242023-02-08
00609271950917MECRON Knee PediatricOS302001OS3020012023-02-08
00609271950924MECRON Knee PediatricOS303001OS3030012023-02-08
00609271950931MECRON Knee PediatricOS304001OS3040012023-02-08
00609271950962MECRON Knee Straight L:400mm, OS:430mm, US:300mmOS400104OS4001042023-02-08
00609271950993MECRON Knee Straight L:400mm, OS:480mm, US:350mmOS400204OS4002042023-02-08
00609271951020MECRON Knee Straight L:400mm, OS:530mm, US:400mmOS400304OS4003042023-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810003753731KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753755KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753854KENAFLEXXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753878KENAFLEXX KENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753892KENAFLEXXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753915KENAFLEXXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753533KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753557KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753571KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753595KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753618KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753632KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753656KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753670KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753779KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753793KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753816KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753830KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00609271040021Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.NOC2023-11-02
00609271040038Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.NOC2023-11-02
00609271040045Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.NOC2023-11-02
00609271040229Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.NOC2023-11-02
00609271040236Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.NOC2023-11-02
00609271040243Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.NOC2023-11-02
00609271040007Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.NOC2023-09-22
00609271040014Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.NOC2023-09-22
00609271040052Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.NOC2023-09-22
00609271040069Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.NOC2023-09-22