AlboGraft Polyester Vascular Graft AMC1006

GUDID 00840663102853

AlboGraft Polyester Vascular Graft 100cmx6mm

LEMAITRE VASCULAR, INC.

Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft
Primary Device ID00840663102853
NIH Device Record Key50cc6a71-6631-47c3-a0a5-af54fbd6bf29
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlboGraft Polyester Vascular Graft
Version Model NumberAMC1006
Catalog NumberAMC1006
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 Numbertrue
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@lemeitre.com
Phone781-221-2266
Emailcsus@lemeitre.com
Phone781-221-2266
Emailcsus@lemeitre.com
Phone781-221-2266
Emailcsus@lemeitre.com
Phone781-221-2266
Emailcsus@lemeitre.com
Phone781-221-2266
Emailcsus@lemeitre.com
Phone781-221-2266
Emailcsus@lemeitre.com
Phone781-221-2266
Emailcsus@lemeitre.com
Phone781-221-2266
Emailcsus@lemeitre.com
Phone781-221-2266
Emailcsus@lemeitre.com
Phone781-221-2266
Emailcsus@lemeitre.com
Phone781-221-2266
Emailcsus@lemeitre.com
Phone781-221-2266
Emailcsus@lemeitre.com
Phone781-221-2266
Emailcsus@lemeitre.com
Phone781-221-2266
Emailcsus@lemeitre.com
Phone781-221-2266
Emailcsus@lemeitre.com
Phone781-221-2266
Emailcsus@lemeitre.com
Phone781-221-2266
Emailcsus@lemeitre.com
Phone781-221-2266
Emailcsus@lemeitre.com
Phone781-221-2266
Emailcsus@lemeitre.com
Phone781-221-2266
Emailcsus@lemeitre.com
Phone781-221-2266
Emailcsus@lemeitre.com
Phone781-221-2266
Emailcsus@lemeitre.com
Phone781-221-2266
Emailcsus@lemeitre.com
Phone781-221-2266
Emailcsus@lemeitre.com
Phone781-221-2266
Emailcsus@lemeitre.com
Phone781-221-2266
Emailcsus@lemeitre.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840663102853 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MALGraft, Vascular, Synthetic/Biologic Composite

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 Date2015-10-16

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00840663108794 - XenoSure Biologic Patch2021-06-28 XenoSure Biologic Patch, 5cm x 10cm
00840663108800 - XenoSure Biologic Patch2021-06-28 XenoSure Biologic Patch, 12cm x 25cm
00840663108824 - XenoSure Biologic Patch2021-06-28 XenoSure Biologic Patch, 5cm x 10cm, eIFU
00840663108831 - XenoSure Biologic Patch2021-06-28 XenoSure Biologic Patch, 2.5cm x 15cm, eIFU
00840663108916 - YES Tape2021-06-28 YES Tape
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