Intri24 Introducer Sheath 52-101

GUDID 00850291007260

Intri24™ Introducer Sheath (Sheath)

INARI MEDICAL INC

Thrombectomy wire-net introduction set
Primary Device ID00850291007260
NIH Device Record Keyed45e87a-3fd8-416d-aa0d-ff473ab6d9a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntri24 Introducer Sheath
Version Model Number52-101
Catalog Number52-101
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(877) 923-4747
Emailinfo@inarimedical.com
Phone(877) 923-4747
Emailinfo@inarimedical.com
Phone(877) 923-4747
Emailinfo@inarimedical.com
Phone(877) 923-4747
Emailinfo@inarimedical.com
Phone(877) 923-4747
Emailinfo@inarimedical.com
Phone(877) 923-4747
Emailinfo@inarimedical.com
Phone(877) 923-4747
Emailinfo@inarimedical.com
Phone(877) 923-4747
Emailinfo@inarimedical.com
Phone(877) 923-4747
Emailinfo@inarimedical.com
Phone(877) 923-4747
Emailinfo@inarimedical.com
Phone(877) 923-4747
Emailinfo@inarimedical.com
Phone(877) 923-4747
Emailinfo@inarimedical.com
Phone(877) 923-4747
Emailinfo@inarimedical.com
Phone(877) 923-4747
Emailinfo@inarimedical.com
Phone(877) 923-4747
Emailinfo@inarimedical.com
Phone(877) 923-4747
Emailinfo@inarimedical.com
Phone(877) 923-4747
Emailinfo@inarimedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850291007260 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYBIntroducer, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-28
Device Publish Date2023-03-20

Devices Manufactured by INARI MEDICAL INC

00850291007352 - InThrill Thrombectomy Catheter2024-12-30 InThrill Thrombectomy Catheter
00850291007697 - Large Bore 60 cc Syringe2024-12-30 Large Bore 60 cc Syringe
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 System2024-10-18 16 Fr Evacuation System
00810123710485 - 24 Fr Evacuation System2024-10-18 24 Fr Evacuation System

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