Catalog Number

-

Brand Name

NeoForm

Version/Model Number

4200-26

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"

-

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

K190506,K190506

Product Code

KRH

Product Code Name

Ring, Annuloplasty

Public Device Record Key

56fd6f5c-3e9a-4316-afa4-cbee9e4ab639

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

May 22, 2019

Package DI Number

B040420026

Quantity per Package

1

Contains DI Package

B0404200260

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-