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.
B040CRC51
HIBCC

1
939872651 *Terms of Use
Coronary Artery Retraction Clip
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

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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
No 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

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Size Type Text
Length: 5 Millimeter
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Device Record Status

f3edbd45-b216-4168-9029-0e751fe96067
March 29, 2018
2
February 01, 2017
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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
B040CRC52 1 B040CRC51 In Commercial Distribution
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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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
800 786-4890
info@geneseebiomedical.com
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