DEVICE: CARBOMEDICS STANDARD (08022057012746)

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
CARBOMEDICS STANDARD
M7-031
In Commercial Distribution

CORCYM SRL
08022057012746
GS1

1
441454802 *Terms of Use
No description.
CLOSE

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?
60241 Mitral bi-leaflet mechanical heart valve prosthesis
An artificial substitute for a natural mitral heart valve intended to be implanted during open heart surgery typically to treat acquired or congenital valvular disease. It consists of two flat, semicircular, pyrolytic carbon-coated or polymer leaflets that pivot about pyrolytic carbon or metal struts attached to the valve housing by hinges; the hinge points intersect the valve lumen resulting in a total of three openings. When pressurized blood hits the valve, the two halves of the circle fold away from the valve ring and allow blood to flow into the three openings before the valve flaps close again.
Active true
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
LWQ HEART-VALVE, MECHANICAL
CLOSE

FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
P900060 002
P900060 003
P900060 006
P900060 007
P900060 009
P900060 010
P900060 013
P900060 014
P900060 020
P900060 023
P900060 030
P900060 032
P900060 033
P900060 034
P900060 037
P900060 039
P900060 041
P900060 049
P900060 050
No CLOSE

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

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status
894f3d4b-fb00-48b0-bd5c-3d7e379d72ff
May 16, 2025
6
July 23, 2014
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

[?]
No
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE