QCS-14-20.0-10T

GUDID 00815212025716

Izi Medical Products, LLC

Soft-tissue biopsy procedure kit, non-medicated
Primary Device ID00815212025716
NIH Device Record Key06168805-c9c9-4921-9bd5-76db1ca76bcf
Commercial Distribution StatusIn Commercial Distribution
Brand NameQCS-14-20.0-10T
Version Model NumberG28109
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
GS100815212025716 [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 Date2021-10-28
Device Publish Date2021-10-20

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00815212026881 - BKP-11-12.0-15.0-A2024-07-08
00815212026867 - MDT NAVIGATED BIOPSY, COMPATIABLE 7D2024-03-26

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