ShadowForm Marker

GUDID 00815212021725

Izi Medical Products, LLC

Radiographic image marker, manual Radiographic image marker, manual
Primary Device ID00815212021725
NIH Device Record Key3547c29b-dc64-4c2d-bcf8-13e1640984b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameShadowForm Marker
Version Model NumberSF5001
Company DUNS933506164
Company NameIzi Medical Products, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS100815212021725 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPQSystem, Simulation, Radiation Therapy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-17

On-Brand Devices [ShadowForm Marker]

00815212022074S-SF5003
00815212022067S-SF5002
00815212022050S-SF5001
00815212021749SF5003
00815212021732SF5002
00815212021725SF5001
00815212021718VIP1740
00815212021701VIP1735
00815212021695VIP1710

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