Catalog Number

-

Brand Name

SINGLE USE DISTAL COVER

Version/Model Number

MAJ-2315

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K193182,K193182,K193182

Product Code

FDT

Product Code Name

Duodenoscope and accessories, flexible/rigid

Public Device Record Key

f6f47962-8b03-41c7-8f86-8065d5e205c9

Public Version Date

September 05, 2022

Public Version Number

4

DI Record Publish Date

January 27, 2020

Package DI Number

14953170403016

Quantity per Package

20

Contains DI Package

04953170403019

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-