Catalog Number

-

Brand Name

BALLOON SHEATH

Version/Model Number

MH-246R

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 10, 2022

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

K961048,K961048

Product Code

FED

Product Code Name

endoscopic access overtube, gastroenterology-urology

Public Device Record Key

ab5dd98d-72a4-4c99-9eaa-ff2a49acecd6

Public Version Date

August 11, 2022

Public Version Number

4

DI Record Publish Date

October 12, 2017

Package DI Number

14953170058995

Quantity per Package

5

Contains DI Package

04953170058998

Package Discontinue Date

August 10, 2022

Package Status

Not in Commercial Distribution

Package Type

-