Catalog Number

-

Brand Name

SCOPE BUDDY TUBING

Version/Model Number

SB-110-HU1001

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"

-

For Single-Use

-

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

FEB

Product Code Name

Accessories, Cleaning, For Endoscope

Public Device Record Key

d509cfa5-8f79-4ab1-b174-8ea241b2e604

Public Version Date

April 27, 2022

Public Version Number

7

DI Record Publish Date

October 10, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-