Catalog Number

-

Brand Name

TruClear

Version/Model Number

7209509

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

HIH

Product Code Name

HYSTEROSCOPE (AND ACCESSORIES)

Public Device Record Key

8e365faa-24c4-4c41-8b1a-7075681af187

Public Version Date

March 21, 2022

Public Version Number

3

DI Record Publish Date

October 16, 2017

Package DI Number

90884521744109

Quantity per Package

999

Contains DI Package

10884521744103

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE