Catalog Number

-

Brand Name

Unicare Manipulator

Version/Model Number

100041

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

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

K163214

Product Code

LKF

Product Code Name

Cannula, Manipulator/Injector, Uterine

Public Device Record Key

b1c2ed17-cc1a-421f-94eb-6d46ba537034

Public Version Date

December 07, 2018

Public Version Number

4

DI Record Publish Date

November 19, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-