Catalog Number

-

Brand Name

BAILEY AORTIC VALVE RONGEUR

Version/Model Number

440-313

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 22, 2018

Issuing Agency

In HIBCC

MRI safety Status

Labeling does not contain MRI Safety Information

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K092544

Product Code

HTX

Product Code Name

Rongeur

Public Device Record Key

230ba2e7-2bee-43a3-84f0-d039ecc8ebac

Public Version Date

July 12, 2019

Public Version Number

6

DI Record Publish Date

August 08, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-