FDA.reportPublic FDA data

DARCO® Night Splint

Primary DI
00609271809154
Brand
DARCO® Night Splint
Company
DARCO INTERNATIONAL, INC.
Model
NS1B
Catalog number
NS1B; PNS1B
Device description
Small Black Pneumatic
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
10609271809151PackageGS14In Commercial Distribution
20609271809158PackageGS112In Commercial Distribution
00609271809154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060927180915110609271809151
2060927180915820609271809158
00609271809154006092718091546092718091540609271809154

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
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