DEVICE: XenoSure Biologic Patch (00840663106349)

Device Identifier (DI) Information

XenoSure Biologic Patch
e10P16
In Commercial Distribution
e10P16
Lemaitre Vascular, Inc.
00840663106349
GS1

1
184805166 *Terms of Use
XenoSure Biologic Patch, 10cm x 16cm, eIFU
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
35273 Cardiovascular patch, animal-derived
An implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a patch made of, or coated/impregnated with, materials of animal origin (e.g., porcine, bovine, or equine pericardium/collagen), that is typically implanted with sutures.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
FTM Mesh, Surgical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K040835 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 0 and 40 Degrees Celsius
Handling Environment Temperature: between 0 and 40 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

c1784a19-1e90-4e8e-a14b-1425308f095a
April 21, 2021
5
July 15, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
781-221-2266
csus@lemaitre.com
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