FDA.reportPublic FDA data

Dynarex ActiSplint

Primary DI
00616784353029
Brand
Dynarex ActiSplint
Company
Dynarex Corporation
Model
3530
Device description
Dynarex ActiSplint Finger Version, Finger Splints, Breathable, Red/Charcoal Gray
Published
2021-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00616784353036PackageGS130In Commercial Distribution
00616784353029PrimaryGS10
00810180845038Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784353036006167843530366167843530360616784353036
00616784353029006167843530296167843530290616784353029
00810180845038008101808450388101808450380810180845038

GMDN Terms#

Term, Definition table
TermDefinition
Hand/finger splint, reusableA prefabricated (non-customized) wearable rigid or semi-rigid device intended to immobilize an injured/diseased hand and/or finger to support, align or prevent injury during the healing process. It is applied externally to the hand/finger/wrist and typically held in place with self-retaining fasteners (e.g., Velcro bands) or bandage wraps. This is a reusable device.

Regulatory Flags#

DUNS number
008124539
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

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00616784671826SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrous67182026-09-30
00616784671925SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrous67192026-09-30
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