Catalog Number

-

Brand Name

FlexForm Annuloplasty Band

Version/Model Number

FBH-28

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K161815,K161815

Product Code

KRH

Product Code Name

Ring, Annuloplasty

Public Device Record Key

d4e2df5d-46b9-438e-918a-2869efa97498

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

February 02, 2017

Package DI Number

B040FBH28

Quantity per Package

1

Contains DI Package

B040FBH280

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-