Catalog Number

7210165

Brand Name

Hysteroscopic Fluid Management System Stand

Version/Model Number

7210165

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K031616

Product Code

HIG

Product Code Name

INSUFFLATOR, HYSTEROSCOPIC

Public Device Record Key

5a05dab7-042b-4821-8244-b8b959850dd3

Public Version Date

October 24, 2022

Public Version Number

5

DI Record Publish Date

September 28, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-