16 Fr Evacuation System

GUDID 00810123710478

16 Fr Evacuation System

INARI MEDICAL INC

Thrombectomy suction catheter
Primary Device ID00810123710478
NIH Device Record Key957dccf0-4050-4c06-b12e-dd551f66f95d
Commercial Distribution StatusIn Commercial Distribution
Brand Name16 Fr Evacuation System
Version Model Number131-101 / AS-01226
Company DUNS076827459
Company NameINARI MEDICAL INC
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18779234747
Emailinfo@inarimedical.com
Phone18779234747
Emailinfo@inarimedical.com
Phone18779234747
Emailinfo@inarimedical.com
Phone18779234747
Emailinfo@inarimedical.com
Phone18779234747
Emailinfo@inarimedical.com
Phone18779234747
Emailinfo@inarimedical.com
Phone18779234747
Emailinfo@inarimedical.com
Phone18779234747
Emailinfo@inarimedical.com
Phone18779234747
Emailinfo@inarimedical.com
Phone18779234747
Emailinfo@inarimedical.com
Phone18779234747
Emailinfo@inarimedical.com
Phone18779234747
Emailinfo@inarimedical.com
Phone18779234747
Emailinfo@inarimedical.com
Phone18779234747
Emailinfo@inarimedical.com
Phone18779234747
Emailinfo@inarimedical.com
Phone18779234747
Emailinfo@inarimedical.com
Phone18779234747
Emailinfo@inarimedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810123710478 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PURVacuum Syringe

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-18
Device Publish Date2024-10-10

Devices Manufactured by INARI MEDICAL INC

00810123710577 - Artix Thin-Walled Sheath2024-11-19 Artix Thin-Walled Sheath
00810123710584 - Artix MT2024-11-19 Artix MT (Thrombectomy Device)
00810123710591 - Artix MT2024-11-19 Artix MT (Thrombectomy Device)
00810123710560 - Artix Thin-Walled Sheath2024-11-15 Artix Thin-Walled Sheath (Thrombectomy Sheath)
00810123710478 - 16 Fr Evacuation System2024-10-1816 Fr Evacuation System
00810123710478 - 16 Fr Evacuation System2024-10-18 16 Fr Evacuation System
00810123710485 - 24 Fr Evacuation System2024-10-18 24 Fr Evacuation System
00810123710546 - FlowSaver2024-06-06 FlowSaver
00810123710096 - Triever242024-04-25

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