Catalog Number

-

Brand Name

Tube set for irrigation, single-use

Version/Model Number

Z0449-01

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K022449,K022449

Product Code

HIG

Product Code Name

Insufflator, Hysteroscopic

Public Device Record Key

9b163f83-352f-49e8-9fde-0e089e0239ca

Public Version Date

April 23, 2019

Public Version Number

5

DI Record Publish Date

August 01, 2016

Package DI Number

04056702000103

Quantity per Package

10

Contains DI Package

04056702000097

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-