Catalog Number

1240-16

Brand Name

Medovations®

Version/Model Number

1240-16

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

-

Product Code

GBS

Product Code Name

Catheter, Ventricular, General & Plastic Surgery

Public Device Record Key

b428c188-7e5a-482f-b507-d092839f17e5

Public Version Date

April 10, 2019

Public Version Number

4

DI Record Publish Date

December 23, 2016

Package DI Number

M7831240161

Quantity per Package

10

Contains DI Package

M7831240160

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case