Catalog Number

1203-72

Brand Name

BullDog

Version/Model Number

1203-72

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)

Yes

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

OCX

Product Code Name

Endoscopic Irrigation/Suction System

Public Device Record Key

883a9a58-3de0-48d4-ab3e-5aa9bc6681ca

Public Version Date

October 21, 2020

Public Version Number

2

DI Record Publish Date

August 09, 2019

Package DI Number

10816734021344

Quantity per Package

50

Contains DI Package

00816734021347

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case