CT Thrombectomy System Kit

GUDID 00850291007154

CT Thrombectomy System Kit - Contains x1 ClotTriever Catheter (40-102) and x1 ClotTriever Sheath (50-101)

INARI MEDICAL INC

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Primary Device ID00850291007154
NIH Device Record Key63b79a03-3529-4d87-a0c8-788adf7a6636
Commercial Distribution StatusIn Commercial Distribution
Brand NameCT Thrombectomy System Kit
Version Model Number90-101
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 Kittrue
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

Phone949-600-8433
Emailinfo@inarimedical.com
Phone949-600-8433
Emailinfo@inarimedical.com
Phone949-600-8433
Emailinfo@inarimedical.com
Phone949-600-8433
Emailinfo@inarimedical.com
Phone949-600-8433
Emailinfo@inarimedical.com
Phone949-600-8433
Emailinfo@inarimedical.com
Phone949-600-8433
Emailinfo@inarimedical.com
Phone949-600-8433
Emailinfo@inarimedical.com
Phone949-600-8433
Emailinfo@inarimedical.com
Phone949-600-8433
Emailinfo@inarimedical.com
Phone949-600-8433
Emailinfo@inarimedical.com
Phone949-600-8433
Emailinfo@inarimedical.com
Phone949-600-8433
Emailinfo@inarimedical.com
Phone949-600-8433
Emailinfo@inarimedical.com
Phone949-600-8433
Emailinfo@inarimedical.com
Phone949-600-8433
Emailinfo@inarimedical.com
Phone949-600-8433
Emailinfo@inarimedical.com
Phone949-600-8433
Emailinfo@inarimedical.com
Phone949-600-8433
Emailinfo@inarimedical.com
Phone949-600-8433
Emailinfo@inarimedical.com
Phone949-600-8433
Emailinfo@inarimedical.com
Phone949-600-8433
Emailinfo@inarimedical.com
Phone949-600-8433
Emailinfo@inarimedical.com
Phone949-600-8433
Emailinfo@inarimedical.com
Phone949-600-8433
Emailinfo@inarimedical.com
Phone949-600-8433
Emailinfo@inarimedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850291007154 [Primary]

FDA Product Code

DXECatheter, Embolectomy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-03-21
Device Publish Date2018-12-18

Devices Manufactured by INARI MEDICAL INC

00810123710096 - Triever242024-04-25
00810123710140 - ClotTriever Catheter2024-04-25 ClotTriever, 16mm
00810123710065 - Triever202024-04-24 Triever20
00850291007475 - Triever LA Transseptal Sheath2024-04-23 Triever LA Transseptal Sheath
00850291007406 - VenaCore Thrombectomy Catheter2024-04-04 VenaCore Thrombectomy Catheter
00810123710058 - ClotTriever Sheath, 13 Fr2023-12-25 ClotTriever Sheath, 13 Fr (ClotTriever Thrombectomy System)
00810123710430 - ClotTriever Sheath, 16 Fr2023-12-25 ClotTriever Sheath, 16 Fr (ClotTriever Thrombectomy System)
00810123710522 - Triever20 Curve2023-12-25 Triever20 Curve

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