DEVICE: AORTIC ROOT RETRACTOR (00850200006551)

Device Identifier (DI) Information

AORTIC ROOT RETRACTOR
080300
In Commercial Distribution
080300
LSI Solutions, Inc.
00850200006551
GS1

1
603420183 *Terms of Use
AORTIC ROOT RETRACTOR, SMALL
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Device Characteristics

Labeling does not contain MRI Safety Information
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?
64618 Aortic root retraction system
An assembly of devices intended to be used during aortic valve replacement via aortotomy to facilitate temporary stabilization of the aortic root for improved aortic valve site exposure, visualization and tissue tension. It consists of a circular frame that is placed within the aortic ring, sutures and suture retaining loops, and a deployment device with handle and shaft; it may be used during minimally-invasive and open surgery. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DWS INSTRUMENTS, SURGICAL, CARDIOVASCULAR
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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
Outer Diameter: 24 Millimeter
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Device Record Status

467d1226-607c-44f5-952c-b043afcf0d95
November 14, 2022
4
March 13, 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
10850200006558 6 00850200006551 2022-11-12 Not in Commercial Distribution Inner pack
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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
Yes
No
No CLOSE

Customer Contact

[?]
+1(866)575-3493
regulatorydpt@lsisolutions.com
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