Catalog Number

-

Brand Name

Mui Scientific

Version/Model Number

PC-SEI4

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

K192691,K192691

Product Code

FED

Product Code Name

Endoscopic Access Overtube, Gastroenterology-Urology

Public Device Record Key

33bfef8c-0f34-402d-b501-aa2e9af47d7d

Public Version Date

August 22, 2022

Public Version Number

4

DI Record Publish Date

December 17, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-