Catalog Number

-

Brand Name

TRUCLEAR

Version/Model Number

72204752

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K152143

Product Code

HIH

Product Code Name

HYSTEROSCOPE (AND ACCESSORIES)

Public Device Record Key

0a4ba084-4bcf-4387-9b71-7e0467e4a7b9

Public Version Date

April 01, 2022

Public Version Number

4

DI Record Publish Date

September 21, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-