DEVICE: XenoSure Biologic Pledgets (00840663109340)

Device Identifier (DI) Information

XenoSure Biologic Pledgets
PL0506R25
In Commercial Distribution
PL0506R25
Lemaitre Vascular, Inc.
00840663109340
GS1

1
184805166 *Terms of Use
XenoSure Biologic Pledgets, 0.5cm x 0.6cm, 25-Count
CLOSE

Device Characteristics

MR Safe
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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
FTM Mesh, Surgical
CLOSE

FDA Premarket Submission

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

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 0 and 40 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

d619cf85-36fb-4dc0-8ce5-04b05b628395
June 28, 2021
1
June 18, 2021
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

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