Multi-Modality Markers

GUDID 00815212020766

Izi Medical Products, LLC

Radiographic image marker, manual
Primary Device ID00815212020766
NIH Device Record Key8d38a55f-f412-41de-b652-93c638dc86bf
Commercial Distribution StatusIn Commercial Distribution
Brand NameMulti-Modality Markers
Version Model NumberMM3005
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815212020766 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, Linear, Medical

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 Date2017-01-25

On-Brand Devices [Multi-Modality Markers]

00815212022869S-MM3005
00815212022845S-MM3002
00815212022784MM3005-VIP
00815212022777MM3005CLM
00815212022753REG3002
00815212020773MM3007
00815212020766MM3005
00815212020759MM3003
00815212020742MM3002-60
00815212020735MM3002-10I
00815212020728MM3002-100
00815212020711MM3002-10
00815212020704MM3002
0081521202027852160
00815212020261960-991
10815212020268960-991

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