2PK 0.8X3.0MM GOLD FIDUCIAL LOOSE

GUDID 00815212021336

Izi Medical Products, LLC

Imaging lesion localization marker, implantable
Primary Device ID00815212021336
NIH Device Record Keyaf256654-a1e6-40a4-b776-f3dbe016c479
Commercial Distribution StatusIn Commercial Distribution
Brand Name2PK 0.8X3.0MM GOLD FIDUCIAL LOOSE
Version Model NumberGF0302
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
GS100815212021336 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KXKSource, Brachytherapy, Radionuclide

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-25
Device Publish Date2021-10-15

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