Catalog Number

1203-10

Brand Name

BullDog®

Version/Model Number

1203-10

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"

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

9d1ece70-38c5-4be2-ae4c-e352306350bf

Public Version Date

March 19, 2021

Public Version Number

8

DI Record Publish Date

September 17, 2016

Package DI Number

M7831203101

Quantity per Package

100

Contains DI Package

M7831203100

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case