DEVICE: XenoSure Biologic Patch (00840663106288)
Device Identifier (DI) Information
XenoSure Biologic Patch
e1P6
In Commercial Distribution
e1P6
Lemaitre Vascular, Inc.
e1P6
In Commercial Distribution
e1P6
Lemaitre Vascular, Inc.
XenoSure Biologic Patch, 1cm x 6cm
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FTM | Mesh, Surgical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K040835 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 0 and 40 Degrees Celsius |
Handling Environment Temperature: between 0 and 40 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
2acae682-4798-4e31-acc9-9fd225c2f77d
April 21, 2021
5
July 15, 2015
April 21, 2021
5
July 15, 2015
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
781-221-2266
csus@lemaitre.com
csus@lemaitre.com