SC

GUDID 00026072022894

6 SPLINT KIT

Allied Medical, LLC

Inflatable extremity splint
Primary Device ID00026072022894
NIH Device Record Key04544af8-0097-4377-bb87-cb439aa1bd73
Commercial Distribution StatusIn Commercial Distribution
Brand NameSC
Version Model NumberS520
Company DUNS119066872
Company NameAllied Medical, LLC
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100026072022894 [Primary]

FDA Product Code

FYHSplint, Extremity, Noninflatable, External, Sterile

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-17
Device Publish Date2024-05-09

On-Brand Devices [SC]

000260720229004 MINI SPLINT
000260720228946 SPLINT KIT
00026072022825ADULT HAND & WRIST
00026072022818ADULT FULL LEG
00026072022801ADULT 1/2 LEG
00026072022795ADULT FULL ARM
00026072022788ADULT 1/2 ARM
00026072022771SPLINT KIT (%
00026072012208ADULT FOOT AND ANKLE SPLINT
00026072012215BLUE TIP TUBIN

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