FDA.report

Dynarex ActiSplint

Primary DI
00616784353036
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
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
00616784353036PackageGS130In Commercial Distribution
00616784353029PrimaryGS10
00616784353012Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784353036006167843530366167843530360616784353036
00616784353029006167843530296167843530290616784353029
00616784353012006167843530126167843530120616784353012

GMDN Terms

TermDefinition
Hand/finger splint, reusableA 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
10
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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