Catalog Number

-

Brand Name

Polygon

Version/Model Number

50-100

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"

Yes

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

K182675,K182675

Product Code

HIH

Product Code Name

Hysteroscope (And Accessories)

Public Device Record Key

be0e24da-3e86-43c9-8efa-c4963acbab8a

Public Version Date

August 16, 2019

Public Version Number

2

DI Record Publish Date

June 03, 2019

Package DI Number

10860001020608

Quantity per Package

3

Contains DI Package

00860001020601

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case