Catalog Number

1203-71

Brand Name

Medovations® BullDog®

Version/Model Number

1203-71

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OCX

Product Code Name

Endoscopic Irrigation/Suction System

Public Device Record Key

c68dab8c-1bd2-4376-8d73-1e6d10f7a7ed

Public Version Date

April 10, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2018

Package DI Number

10816734021337

Quantity per Package

50

Contains DI Package

00816734021330

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case