FDA.report

Dynarex ActiSplint

Primary DI
00616784352831
Brand
Dynarex ActiSplint
Company
DYNAREX CORPORATION
Model
3528
Device description
Dynarex ActiSplint Rolled, 36in. Rolled Splint, Breathable, Red/Charcoal Gray
Published
2021-09-01
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
false

Related Records

Product Codes

CodeName
NOCSplint, Extremity, Non-Inflatable, External, Non-Sterile

Product Code Classifications

CodeDeviceSpecialtyClass
NOCSplint, Extremity, Non-Inflatable, External, Non-SterileGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784352831PackageGS150In Commercial Distribution
00616784352817PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784352831006167843528316167843528310616784352831
00616784352817006167843528176167843528170616784352817

GMDN Terms

TermDefinition
First aid limb splint, mouldable, reusableA portable device intended to be used for emergency immobilization of an injured body extremity (arm or leg). It takes the form of a semi-rigid, padded, metallic sheet, or a wire frame, designed to be manually moulded/curved externally around the limb to create a rigid splint. It is typically intended to be used by emergency medical services (EMS). This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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