Catalog Number

-

Brand Name

ClearView

Version/Model Number

DSD-2000

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

K940681,K940681

Product Code

LKF

Product Code Name

Cannula, Manipulator/Injector, Uterine

Public Device Record Key

f6aecb3b-e4cf-43f9-a4b8-81f090a916a1

Public Version Date

December 07, 2018

Public Version Number

4

DI Record Publish Date

September 01, 2016

Package DI Number

10814247020144

Quantity per Package

50

Contains DI Package

00814247020147

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-