EndoHelix Retrieval Device 4200-20

GUDID 00840663102587

EndoHelix Retrieval Device

LEMAITRE VASCULAR, INC.

Intraluminal artery stripper, single-use
Primary Device ID00840663102587
NIH Device Record Key9afdd229-9fc4-46c6-a9f8-770db2f90952
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoHelix Retrieval Device
Version Model Number4200-20
Catalog Number4200-20
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 Latexfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840663102587 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWXStripper, Artery, Intraluminal

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 Date2015-06-30

Devices Manufactured by LEMAITRE VASCULAR, INC.

00840663110551 - CardioCel Bioscaffold Patch 4 cm X 4 cm2024-10-18
00840663110568 - CardioCel Bioscaffold Patch 5 cm X 8 cm2024-10-18
00840663110575 - CardioCel Bioscaffold Patch 6 cm X 14 cm2024-10-18
00840663110605 - CardioCel Neo Bioscaffold Patch 4 cm X 4 cm 2024-10-18
00840663110667 - VascuCel Bioscaffold Patch .8 cm X 8 cm2024-10-18
00840663110674 - VascuCel Bioscaffold Patch 1 cm X 14 cm2024-10-18
00840663110773 - CardioCel Neo Bioscaffold Patch 5 cm X 8 cm2024-10-18
00840663110544 - CardioCel Bioscaffold Patch 2 cm X 2 cm2024-10-16

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.