DEVICE: FlexForm Annuloplasty Band (B040FBH320)

Device Identifier (DI) Information

FlexForm Annuloplasty Band
FBH-32
In Commercial Distribution

GENESEE BIOMEDICAL, INC.
B040FBH320
HIBCC

1
939872651 *Terms of Use
Annuloplasty Band
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Device Characteristics

MR Conditional
No
Yes
Yes
No
No
No
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Mitral/tricuspid annuloplasty ring A sterile circular band intended to be implanted in the heart for the reconstruction and/or remodelling of insufficient and/or stenotic mitral and tricuspid valves. It is typically mounted on a disposable holder assembly to enable it to maintain its shape and aid in its implantation with sutures. The device may be semi-rigid or flexible and may include metallic, polymeric, and/or textile materials; it is available in various sizes.
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FDA Product Code

[?]
Product Code Product Code Name
KRH Ring, Annuloplasty
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K161815 000
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

[?]
Size Type Text
No Device Sizes
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Device Record Status

1760f17f-6e89-4c69-b596-111762685f3b
July 06, 2018
3
February 02, 2017
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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
B040FBH32 1 B040FBH320 In Commercial Distribution
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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
Yes
Yes
Yes
No CLOSE

Customer Contact

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