ActiSplint with Sensi-Wrap

GUDID 00840117349247

ActiSplint with Sensi-Wrap 2"x5yds, Red/Charcoal Gray Rolled Splint, Black Self-Adherent Bandage, 36" ActiSplint, 2"x5 Sensi Wrap; Combo Packs

Dynarex Corporation

General-purpose medical foam padding, single-use
Primary Device ID00840117349247
NIH Device Record Keyf9e1f5e7-645d-45e4-9c14-1f5061b6b583
Commercial Distribution StatusIn Commercial Distribution
Brand NameActiSplint with Sensi-Wrap
Version Model Number3533
Company DUNS008124539
Company NameDynarex Corporation
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840117349247 [Primary]
GS100840117349254 [Package]
Package: Case [50 Units]
In Commercial Distribution

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2026-03-18
Device Publish Date2021-09-01

On-Brand Devices [ActiSplint with Sensi-Wrap]

00616784353319ActiSplint with Sensi-Wrap 2"x5yds, Red/Charcoal Gray Rolled Splint, Black Self-Adherent Bandage
00840117349247ActiSplint with Sensi-Wrap 2"x5yds, Red/Charcoal Gray Rolled Splint, Black Self-Adherent Bandage

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