DualCore Biopsy System w/Coax-14g x 10cm

GUDID 00815212026089

Izi Medical Products, LLC

Soft-tissue biopsy procedure kit, non-medicated
Primary Device ID00815212026089
NIH Device Record Key1f87a7cc-f4c4-40e0-a86e-1a4235be5f2a
Commercial Distribution StatusIn Commercial Distribution
Brand NameDualCore Biopsy System w/Coax-14g x 10cm
Version Model NumberMCNX1410
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 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
GS100815212026089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNWInstrument, Biopsy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-30
Device Publish Date2022-05-20

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