QUICK-CORE BIOPSY QC-20-9.0-20T

GUDID 00815212023965

Izi Medical Products, LLC

Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated
Primary Device ID00815212023965
NIH Device Record Key95f5f4c6-098f-493e-9c30-6672c1999f6a
Commercial Distribution StatusIn Commercial Distribution
Brand NameQUICK-CORE BIOPSY QC-20-9.0-20T
Version Model NumberG27015
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
GS100815212023965 [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 Date2021-06-10
Device Publish Date2021-06-02

Devices Manufactured by Izi Medical Products, LLC

00815212023965 - QUICK-CORE BIOPSY QC-20-9.0-20T2021-06-10
00815212023965 - QUICK-CORE BIOPSY QC-20-9.0-20T2021-06-10
00815212023972 - QCS-14-9.0-20T-QCS-TN-11-5.4-M3-IS2021-06-10
00815212023989 - QCS-16-15.0-20T-QCS-TN-14XT-11.6-M32021-06-10
00815212023996 - QCS-16-9.0-20T-QCS-TN-14XT-5.6-M32021-06-10
00815212023903 - QUICK-CORE BIOPSY QC-18-6.0-20T2021-06-04
00815212023910 - QC-18-9.0-10T2021-06-04
00815212023927 - QUICK-CORE BIOPSY QC-18-9.0-20T2021-06-04
00815212023934 - QUICK-CORE BIOPSY QC-20-15.0-10T2021-06-04

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