DEVICE: Tyke, Patch, Pledget and Intracardiac (00859389005102)

Device Identifier (DI) Information

Tyke, Patch, Pledget and Intracardiac
CMCV-098-204
In Commercial Distribution

Elutia Med LLC
00859389005102
GS1

1
080924060 *Terms of Use
Tyke is intended for use in neonates and infants for repair of pericardial structures, as an epicardial covering for damaged or repaired cardiac structures, as a patch material for intracardiac defects, septal defect and annulus repair, suture-line buttressing, and cardiac repair.
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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
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FDA Product Code

[?]
Product Code Product Code Name
DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K152127 000
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 10 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Height: 4 Centimeter
Width: 7 Centimeter
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Device Record Status

c8709cb5-e244-44be-8415-8acfa66ba448
September 24, 2024
3
February 28, 2019
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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
10859389005109 5 00859389005102 In Commercial Distribution Box
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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

[?]
470-514-4080
xxx@xx.xx
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