DEVICE: AORTIC ROOT RETRACTOR (00850200006551)
Device Identifier (DI) Information
AORTIC ROOT RETRACTOR
080300
In Commercial Distribution
080300
LSI Solutions, Inc.
080300
In Commercial Distribution
080300
LSI Solutions, Inc.
AORTIC ROOT RETRACTOR, SMALL
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DWS | INSTRUMENTS, SURGICAL, CARDIOVASCULAR |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Outer Diameter: 24 Millimeter |
Device Record Status
467d1226-607c-44f5-952c-b043afcf0d95
November 14, 2022
4
March 13, 2020
November 14, 2022
4
March 13, 2020
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(866)575-3493
regulatorydpt@lsisolutions.com
regulatorydpt@lsisolutions.com