Catalog Number

-

Brand Name

VIKY

Version/Model Number

AV0903

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K122820

Product Code

LKF

Product Code Name

Cannula, Manipulator/Injector, Uterine

Public Device Record Key

9bdb9796-b4f2-452d-8a64-0f5324a97392

Public Version Date

March 11, 2019

Public Version Number

3

DI Record Publish Date

April 05, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-