RevCore Thrombectomy Catheter 44-101

GUDID 00850291007383

RevCore Thrombectomy Catheter (Thrombectomy Catheter)

INARI MEDICAL INC

Thrombectomy wire-net
Primary Device ID00850291007383
NIH Device Record Keyaf1081e7-cf99-4c5f-8997-12870ce1df3b
Commercial Distribution StatusIn Commercial Distribution
Brand NameRevCore Thrombectomy Catheter
Version Model Number44-101
Catalog Number44-101
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 Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850291007383 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QEWPeripheral Mechanical Thrombectomy With Aspiration

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-04
Device Publish Date2023-03-27

Devices Manufactured by INARI MEDICAL INC

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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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