Hydro LeMaitre Valvulotome e1010-00

GUDID 00840663106837

Hydro LeMaitre Valvulotome (40 cm), eIFU

LEMAITRE VASCULAR, INC.

Valvulotome
Primary Device ID00840663106837
NIH Device Record Key2c3002d1-9b7e-4eee-a580-50334f655095
Commercial Distribution StatusIn Commercial Distribution
Brand NameHydro LeMaitre Valvulotome
Version Model Numbere1010-00
Catalog Numbere1010-00
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
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
GS100840663106837 [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 Date2015-07-15

On-Brand Devices [Hydro LeMaitre Valvulotome]

00840663106837Hydro LeMaitre Valvulotome (40 cm), eIFU
00840663106820Hydro LeMaitre Valvulotome (98 cm), eIFU
008406631066601.5mm HYDRO LeMaitre Valvulotome (40 cm)
008406631066531.5mm HYDRO LeMaitre Valvulotome (98 cm)

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