Catalog Number

72200869

Brand Name

NA

Version/Model Number

72200869

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

HIG

Product Code Name

INSUFFLATOR, HYSTEROSCOPIC

Public Device Record Key

b0d6015f-d443-4579-afa0-f3bb27db16a0

Public Version Date

April 01, 2020

Public Version Number

2

DI Record Publish Date

August 31, 2018

Package DI Number

40884521744074

Quantity per Package

480

Contains DI Package

10884521744073

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE