Catalog Number

KT600LF

Brand Name

Motion Medical Distributing

Version/Model Number

KT600LF

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OKV

Product Code Name

Obstetrical Kit

Public Device Record Key

c52d3c20-2783-4334-a1ff-869a4594731b

Public Version Date

October 22, 2018

Public Version Number

3

DI Record Publish Date

October 04, 2017

Package DI Number

25060498451646

Quantity per Package

10

Contains DI Package

15060498451649

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case