STRYKER FIDUCIAL MARKERS

GUDID 00815212021664

Izi Medical Products, LLC

Radiographic image marker, manual
Primary Device ID00815212021664
NIH Device Record Key9a5161cb-dc1d-4fc5-89c2-1b705e2b8201
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTRYKER FIDUCIAL MARKERS
Version Model Number6000-90-60
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
GS100815212021664 [Primary]
GS110815212021661 [Package]
Package: Box [1 Units]
In Commercial Distribution

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 Date2017-01-06

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