CardioCel Neo Bioscaffold Patch 4 cm X 4 cm

GUDID 00840663110605

Lemaitre Vascular, Inc.

Cardiovascular patch, animal-derived
Primary Device ID00840663110605
NIH Device Record Key33bbbaaa-795c-46e4-a667-c3869556da78
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardioCel Neo Bioscaffold Patch 4 cm X 4 cm
Version Model NumberUC0404N
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 Producttrue
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840663110605 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-18
Device Publish Date2024-10-10

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
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

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