DEVICE: CARBOMEDICS CARBO-SEAL (08022057013521)

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Device Record History
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Device Identifier (DI) Information
CARBOMEDICS CARBO-SEAL
AP-033
In Commercial Distribution

CORCYM SRL
08022057013521
GS1

1
441454802 *Terms of Use
No description.
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Device Characteristics
MR Conditional
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?
60423 Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft
An artificial substitute for a natural aortic heart valve fitted with a length of biologic-polymer blood vessel (vascular graft) intended to be implanted during open heart surgery to simultaneously replace a dysfunctional aortic heart valve and repair/replace a damaged or diseased ascending aorta (e.g., in cases of aneurysm, dissection or dilatation). The valve component consists of two flat, semicircular, pyrolytic carbon-coated or polymer leaflets that pivot about struts attached to the valve housing by hinges; the synthetic polymer blood vessel is designed to conform to the aortic root anatomy and is impregnated with a bioabsorbable animal-derived gelatin.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
LWQ HEART-VALVE, MECHANICAL
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
P900060 012
P900060 013
P900060 014
P900060 020
P900060 030
P900060 032
P900060 033
P900060 034
P900060 037
P900060 039
P900060 041
P900060 049
P900060 050
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Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
0ff76b2c-f60e-4622-8004-392909ef9659
May 19, 2025
6
July 23, 2014
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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

[?]
No
Yes
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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