DEVICE: VALVE XS (04046963954949)

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Device Record History
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Device Identifier (DI) Information
VALVE XS
FC359R
In Commercial Distribution
FC359R
Aesculap AG
04046963954949
GS1

1
315018218 *Terms of Use
VALVE XS VALVE PUSHER 370MMM
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
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?
62685 Heart valve prosthesis repositioning tool
A hand-held manual surgical instrument intended to be used to realign or reposition a heart valve prosthesis after initial insertion and positioning with a heart valve prosthesis holder. The device may be a one-piece instrument or attached to a separate handle, and is available in a range of configurations for the aortic, mitral, or tricuspid heart valve. It is typically made of plastic materials. This is a reusable device intended to be sterilized prior to use.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LXH ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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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
aa8d54c3-bc45-473d-838c-f2ae68f4b246
September 29, 2021
2
June 17, 2020
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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
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)282-9000
GUDID.BBMUS_Service@bbraun.com
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