DEVICE: Perceval S Single Use MICS Accessory Kit (08022057015211)

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Device Record History
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Device Identifier (DI) Information
Perceval S Single Use MICS Accessory Kit
ICV1349
In Commercial Distribution

CORCYM SRL
08022057015211
GS1

1
441454802 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
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?
58987 Self-expandable heart valve bioprosthesis collapsing tool, single-use
A dedicated, manually-operated device designed to reduce the diameter of a self-expanding cardiac valve prosthesis during open and/or transcatheter cardiovascular surgery so the collapsed valve can be mounted onto a dedicated holder or catheter to facilitate implantation. It is available in a variety of designs. This is a single-use device.
Active false
58707 Self-expandable heart valve prosthesis post-dilation balloon catheter
A shaft with an inflatable balloon at its distal end intended to be used during open cardiovascular surgery to dilate the inflow ring of a sutureless cardiac (heart) valve prosthesis, after its implantation and self expansion, to facilitate valve sealing and anchoring. It typically includes a Luer connector at the proximal end and is available in a variety of sizes to fit with the valve sizes. This is a single-use device.
Active false
47680 Heart valve prosthesis holder, single-use
A hand-held, non-powered, invasive surgical instrument designed to hold a cardiac (heart) valve prosthesis or a cardiac annuloplasty ring at, or in proximity to, its site of implantation during surgery. It includes an implant mounting/containing feature and a handle; implantable devices are not included. This is a single-use device.
Active false
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FDA Product Code

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Product Code Product Code Name
No Product Codes
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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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

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Size Type Text
No Device Sizes
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Device Record Status
6615bb99-5f1f-42f0-8199-91bb4166b767
February 08, 2023
7
June 06, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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