FDA.reportPublic FDA data

DARCO® Body Armor® Pro Term

Primary DI
00609271039353
Brand
DARCO® Body Armor® Pro Term
Company
Darco (Europe) GmbH
Model
BAPT3
Catalog number
BAPT3
Device description
Large Black
Published
2023-02-08
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
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
10609271039350PackageGS14In Commercial Distribution
20609271039357PackageGS112In Commercial Distribution
00609271039353PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060927103935010609271039350
2060927103935720609271039357
00609271039353006092710393536092710393530609271039353

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

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
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
10609271040134Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22