DEVICE: Gelseal™ Cardiovascular Patch (05037881010427)

Device Identifier (DI) Information

Gelseal™ Cardiovascular Patch
951010
In Commercial Distribution
951010
VASCUTEK LTD
05037881010427
GS1

1
229053087 *Terms of Use
Gelseal Gelatin Impregnated Knitted Cardiovascular Patch
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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 [?]
K200955 000
K963611 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Store in clean, dry area at room temperature. Vascutek Ltd Sealed Patches must be implanted within one month after removal from the foil pouch.
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Dimensions 10 x 10 cm
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Device Record Status

2b15e1f3-e037-4a20-a1e0-c83621d86805
February 05, 2021
6
October 22, 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
Yes
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)888-3786
tmccustomer.admin@terumomedical.com
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