DEVICE: Intra-Art Coronary Artery Retraction Clip (B040CRC51)
Device Identifier (DI) Information
Intra-Art Coronary Artery Retraction Clip
CRC-5
In Commercial Distribution
GENESEE BIOMEDICAL, INC.
CRC-5
In Commercial Distribution
GENESEE BIOMEDICAL, INC.
Coronary Artery Retraction Clip
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
No | |
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? |
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62493 | Coronary artery exposure retractor |
A sterile, tensionable, surgical instrument designed to be used during cardiac bypass graft anastomosis surgery to provide hands-free (self-retaining) retraction of the fatty surface layer over the myocardium adjacent to the coronary artery, to facilitate exposure of the artery. It is made of stainless steel and is in the form of a clip with leg/prong extensions that uses mechanical spring tension to maintain exposed tissues. 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 [?] |
---|---|
K882981 | 000 |
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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Length: 5 Millimeter |
Device Record Status
f3edbd45-b216-4168-9029-0e751fe96067
July 06, 2018
3
February 01, 2017
July 06, 2018
3
February 01, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
B040CRC52 | 1 | B040CRC51 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
800 786-4890
info@geneseebiomedical.com
info@geneseebiomedical.com