FDA.reportPublic FDA data

DARCO® Body Armor® Night Splint

Primary DI
00609271899964
Brand
DARCO® Body Armor® Night Splint
Company
DARCO INTERNATIONAL, INC.
Model
BADS
Catalog number
BADS
Device description
Standard White
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
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
10609271899961PackageGS14In Commercial Distribution
20609271899968PackageGS112In Commercial Distribution
00609271899964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060927189996110609271899961
2060927189996820609271899968
00609271899964006092718999646092718999640609271899964

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
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
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
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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
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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