FDA.report

DARCO® Night Splint

Primary DI
20609271809455
Brand
DARCO® Night Splint
Company
DARCO INTERNATIONAL, INC.
Model
NS4B
Catalog number
NS4B; PNS4B
Device description
Extra-large Black Pneumatic
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

Related Records

Product Codes

CodeName
FZFSPLINT, EXTREMITY, INFLATABLE, EXTERNAL

Product Code Classifications

CodeDeviceSpecialtyClass
FZFSplint, Extremity, Inflatable, ExternalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10609271809458PackageGS14In Commercial Distribution
20609271809455PackageGS112In Commercial Distribution
00609271809451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1060927180945810609271809458
2060927180945520609271809455
00609271809451006092718094516092718094510609271809451

GMDN Terms

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

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

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00609271120181POGO™ PulsusPGP075NPGP075N2025-04-15

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