BLAZER INTRODUCER,BEVEL TIP

GUDID 00815212023637

Izi Medical Products, LLC

Brain biopsy procedure kit
Primary Device ID00815212023637
NIH Device Record Key71ca00e0-afbd-4d37-8e12-2ba56d3a6d92
Commercial Distribution StatusIn Commercial Distribution
Brand NameBLAZER INTRODUCER,BEVEL TIP
Version Model NumberACC3140
Company DUNS933506164
Company NameIzi Medical Products, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS100815212023637 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OCJSpinal Channeling Instrument, Vertebroplasty

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-24
Device Publish Date2021-05-14

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