Catalog Number

-

Brand Name

Distender II Barostat

Version/Model Number

PPS-9.8

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K991288

Product Code

FFX

Product Code Name

System, Gastrointestinal Motility (Electrical)

Public Device Record Key

f52e7397-6644-4202-98dc-7658fac9c7a9

Public Version Date

July 23, 2020

Public Version Number

4

DI Record Publish Date

November 14, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-