AccessGUDID - DEVICE: FlexForm Annuloplasty Band (B040FBH280)

GUDID

Device Identifier (DI) Information

Brand Name: FlexForm Annuloplasty Band
Version or Model: FBH-28
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GENESEE BIOMEDICAL, INC.

Primary DI Number: B040FBH280
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 939872651 *Terms of Use

Device Description: Annuloplasty Band

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
66338	Mitral/tricuspid annuloplasty ring, open-surgery	A circular band intended to be implanted in the heart during open heart surgery to support a mitral or tricuspid valve annulus for the reconstruction and/or remodelling of insufficient and/or stenotic mitral or tricuspid valves. It is typically mounted on a disposable holder assembly or preloaded in a disposable delivery system to enable it to maintain its shape and aid in its implantation with sutures or anchors. The device may be semi-rigid or flexible and may include metallic, polymeric, and/or textile materials; it is available in various sizes.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KRH	Ring, Annuloplasty

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d4e2df5d-46b9-438e-918a-2869efa97498
Public Version Date: September 28, 2023
Public Version Number: 5
DI Record Publish Date: February 02, 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
B040FBH28	1	B040FBH280		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)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 800 786-4890
Email: info@geneseebiomedical.com

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