QC Auto Set 18G 25CM 25T 5PK

GUDID 00815212025525

Izi Medical Products, LLC

Soft-tissue biopsy procedure kit, non-medicated
Primary Device ID00815212025525
NIH Device Record Key46f3108f-831c-4194-94f2-ed38352a71f2
Commercial Distribution StatusIn Commercial Distribution
Brand NameQC Auto Set 18G 25CM 25T 5PK
Version Model NumberG71825
Company DUNS933506164
Company NameIzi Medical Products, LLC
Device Count5
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
GS100815212025051 [Primary]
GS100815212025525 [Unit of Use]

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 Date2021-06-24
Device Publish Date2021-06-16

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