FDA.reportPublic FDA data

DARCO® Night Splint

Primary DI
20609271809851
Brand
DARCO® Night Splint
Company
DARCO INTERNATIONAL, INC.
Model
NW3B
Catalog number
NW3B; NS3B
Device description
Large Black with Wedge
Published
2023-02-08
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
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
10609271809854PackageGS14In Commercial Distribution
20609271809851PackageGS112In Commercial Distribution
00609271809857PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060927180985410609271809854
2060927180985120609271809851
00609271809857006092718098576092718098570609271809857

GMDN Terms#

Term, Definition table
TermDefinition
Inflatable extremity splintA non-sterile sleeve intended to be placed around an arm or leg and inflated to immobilize and protect the limb. It is typically used by emergency medical services (EMS) as a temporary measure in emergencies, e.g., accidents and motor vehicle crashes, to stabilize the limb for transport to a hospital. 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
00810003753694KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753717KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-19
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