Catalog Number

20400161S

Brand Name

STORZ

Version/Model Number

20400161S

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

-

Product Code

HIF

Product Code Name

Insufflator, Laparoscopic

Public Device Record Key

9a66d9ce-fc88-404d-baf6-05660c7cfa7f

Public Version Date

February 13, 2019

Public Version Number

3

DI Record Publish Date

August 10, 2016

Package DI Number

50628725004353

Quantity per Package

10

Contains DI Package

00628725004358

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-