Catalog Number

1203-73

Brand Name

BullDog

Version/Model Number

1203-73

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

ecb53d8e-6c57-4666-b445-7a4b0151be46

Public Version Date

January 19, 2021

Public Version Number

1

DI Record Publish Date

January 11, 2021

Package DI Number

10816734022761

Quantity per Package

10

Contains DI Package

00816734022764

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case