LeMaitre Embolectomy Catheter e1801-54

GUDID 00840663101054

5F 40 cm NovaSil Silicone Single Lumen Embolectomy Catheter, eIFU

LEMAITRE VASCULAR, INC.

Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter
Primary Device ID00840663101054
NIH Device Record Key40f5f2a5-80b8-494c-9b1a-fcc688d22b5b
Commercial Distribution StatusIn Commercial Distribution
Brand NameLeMaitre Embolectomy Catheter
Version Model Numbere1801-54
Catalog Numbere1801-54
Company DUNS184805166
Company NameLEMAITRE VASCULAR, 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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840663101054 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXECatheter, Embolectomy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-07-15

On-Brand Devices [LeMaitre Embolectomy Catheter]

008406631011087F 80 cm NovaSil Silicone Single Lumen Embolectomy Catheter, eIFU
008406631010927F 40 cm NovaSil Silicone Single Lumen Embolectomy Catheter, eIFU
008406631010856F 80 cm NovaSil Silicone Single Lumen Embolectomy Catheter, eIFU
008406631010786F 40 cm NovaSil Silicone Single Lumen Embolectomy Catheter, eIFU
008406631010615F 80 cm NovaSil Silicone Single Lumen Embolectomy Catheter, eIFU
008406631010545F 40 cm NovaSil Silicone Single Lumen Embolectomy Catheter, eIFU
008406631010474F 80 cm NovaSil Silicone Single Lumen Embolectomy Catheter, eIFU
008406631010304F 40 cm NovaSil Silicone Single Lumen Embolectomy Catheter, eIFU
008406631010233F 80 cm NovaSil Silicone Single Lumen Embolectomy Catheter, eIFU
008406631010163F 40 cm NovaSil Silicone Single Lumen Embolectomy Catheter, eIFU
008406631010092F 60 cm NovaSil Silicone Single Lumen Embolectomy Catheter, eIFU
008406631009962F 40 cm NovaSil Silicone Single Lumen Embolectomy Catheter, eIFU
008406631009897F 80 cm NovaSil Silicone Single Lumen Embolectomy Catheter
008406631009727F 40 cm NovaSil Silicone Single Lumen Embolectomy Catheter
008406631009656F 80 cm NovaSil Silicone Single Lumen Embolectomy Catheter
008406631009586F 40 cm NovaSil Silicone Single Lumen Embolectomy Catheter
008406631009415F 80 cm NovaSil Silicone Single Lumen Embolectomy Catheter
008406631009345F 40 cm NovaSil Silicone Single Lumen Embolectomy Catheter
008406631009274F 80 cm NovaSil Silicone Single Lumen Embolectomy Catheter
008406631009104F 40 cm NovaSil Silicone Single Lumen Embolectomy Catheter
008406631009033F 80 cm NovaSil Silicone Single Lumen Embolectomy Catheter
008406631008973F 40 cm NovaSil Silicone Single Lumen Embolectomy Catheter
008406631008802F 60 cm NovaSil Silicone Single Lumen Embolectomy Catheter
008406631008732F 40 cm NovaSil Silicone Single Lumen Embolectomy Catheter
008406631008665F Plus 80CM Over-the-Wire Embolectomy Catheter, eIFU
008406631008595F Plus 40CM Over-the-Wire Embolectomy Catheter, eIFU
008406631008427F 80CM Over-the-Wire Embolectomy Catheter, eIFU
008406631008356F 80CM Over-the-Wire Embolectomy Catheter, eIFU
008406631008286F 40CM Over-the-Wire Embolectomy Catheter, eIFU
008406631008115F 80CM Over-the-Wire Embolectomy Catheter, eIFU
008406631008045F 40CM Over-the-Wire Embolectomy Catheter, eIFU
008406631007984F 80CM Over-the-Wire Embolectomy Catheter, eIFU
008406631007814F 40CM Over-the-Wire Embolectomy Catheter, eIFU
008406631007743F 80CM Over-the-Wire Embolectomy Catheter, eIFU
008406631007673F 40CM Over-the-Wire Embolectomy Catheter, eIFU
008406631007505F Plus 80CM Over-the-Wire Embolectomy Catheter
008406631007435F Plus 40CM Over-the-Wire Embolectomy Catheter
008406631007367F 80CM Over-the-Wire Embolectomy Catheter
008406631007296F 80CM Over-the-Wire Embolectomy Catheter
008406631007126F 40CM Over-the-Wire Embolectomy Catheter
008406631007055F 80CM Over-the-Wire Embolectomy Catheter
008406631006995F 40CM Over-the-Wire Embolectomy Catheter
008406631006824F 80CM Over-the-Wire Embolectomy Catheter
008406631006754F 40CM Over-the-Wire Embolectomy Catheter
008406631006683F 80CM Over-the-Wire Embolectomy Catheter
008406631006513F 40CM Over-the-Wire Embolectomy Catheter
008406631006447F 80 cm LeMaitre Embolectomy Catheter, eIFU
008406631006376F 80 cm LeMaitre Embolectomy Catheter, eIFU
008406631006205F 80 cm LeMaitre Embolectomy Catheter, eIFU
008406631006135F 40 cm LeMaitre Embolectomy Catheter, eIFU

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