Catalog Number

KSE09014-US

Brand Name

Karl Storz

Version/Model Number

KSE09014-US

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

-

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

-

Product Code

FRG

Product Code Name

Wrap, Sterilization

Public Device Record Key

3a4db0d1-96ee-4d73-8eaf-4056762be04a

Public Version Date

July 08, 2021

Public Version Number

3

DI Record Publish Date

August 02, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-