Catalog Number

SU1161

Brand Name

Medovations®

Version/Model Number

SU1161

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

GBX

Product Code Name

Catheter, Irrigation

Public Device Record Key

5d08df68-8fe1-4d6c-8820-51949518c212

Public Version Date

April 23, 2019

Public Version Number

5

DI Record Publish Date

September 18, 2018

Package DI Number

M783SU11611

Quantity per Package

10

Contains DI Package

M783SU11610

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case