Catalog Number

72203606

Brand Name

TRUCLEARTM Calibration Insert 4.0

Version/Model Number

72203606

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

-

Product Code

HIH

Product Code Name

HYSTEROSCOPE (AND ACCESSORIES)

Public Device Record Key

e480c487-faf6-4f3d-b211-d57f508a77a6

Public Version Date

January 31, 2020

Public Version Number

3

DI Record Publish Date

August 29, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-