Catalog Number

9600CRA

Brand Name

EDWARDS CRIMPER

Version/Model Number

9600CR

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

Yes

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

P140031,P140031,P140031,P140031

Product Code

NPT

Product Code Name

Aortic valve, prosthesis, percutaneously delivered

Public Device Record Key

892b5a37-1fac-4f4b-b751-bbf02b62e040

Public Version Date

July 04, 2022

Public Version Number

9

DI Record Publish Date

December 11, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-