Triever LA Transseptal Sheath 121-101

GUDID 00850291007475

Triever LA Transseptal Sheath

INARI MEDICAL INC

Thrombectomy wire-net introduction set
Primary Device ID00850291007475
NIH Device Record Keyc9d9dde4-44dd-45b4-b6e0-e02856c339f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameTriever LA Transseptal Sheath
Version Model Number121-101/ AS-01084
Catalog Number121-101
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850291007475 [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 Date2024-04-23
Device Publish Date2024-04-15

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 System2024-10-18 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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