QCS-14-9.0-20T-QCS-TN-11-5.4-M3-IS

GUDID 00815212023972

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 ID00815212023972
NIH Device Record Key77165235-c40a-4b01-872d-969f816f7530
Commercial Distribution StatusIn Commercial Distribution
Brand NameQCS-14-9.0-20T-QCS-TN-11-5.4-M3-IS
Version Model NumberG28290
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
GS100815212023972 [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

00815212025365 - QC Auto Set 12G 10CM 25T 5PK2021-06-24
00815212025341 - QC Auto 20G 16CM 25T 5PK2021-06-24
00815212025358 - QC Auto 20G 20CM 25T 5PK2021-06-24
00815212025372 - QC Auto Set 12G 12CM 25T 5PK2021-06-24
00815212025389 - QC Auto Set 12G 16CM 25T 5PK2021-06-24
00815212025396 - QC Auto Set 12G 20CM 25T 5PK2021-06-24
00815212025402 - QC Auto Set 14G 10CM 25T 5PK2021-06-24
00815212025419 - QC Auto Set 14G 12CM 25T 5PK2021-06-24

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.