Retrograde LeMills Valvulotome e1050-00

GUDID 00840663107346

Retrograde LeMills Valvulotome, eIFU

LEMAITRE VASCULAR, INC.

Valvulotome
Primary Device ID00840663107346
NIH Device Record Keyf01b9d1d-9a94-43bf-b8b8-b5680681dc56
Commercial Distribution StatusIn Commercial Distribution
Brand NameRetrograde LeMills Valvulotome
Version Model Numbere1050-00
Catalog Numbere1050-00
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
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100840663107346 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MGZValvulotome

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

On-Brand Devices [Retrograde LeMills Valvulotome]

00840663107346Retrograde LeMills Valvulotome, eIFU
00840663107315Retrograde LeMills Valvulotome

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