Catalog Number

-

Brand Name

BALLOON SHEATH

Version/Model Number

MH-246R

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

K961048,K961048

Product Code

FED

Product Code Name

endoscopic access overtube, gastroenterology-urology

Public Device Record Key

67196d8b-3303-4c5c-8dd9-6d11b3d227d9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

14953170365130

Quantity per Package

5

Contains DI Package

04953170365133

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-