Catalog Number

-

Brand Name

BARIATRIC POWER POSITIONING SYSTEM

Version/Model Number

BPPS-T-RESR

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 12, 2021

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

K182995

Product Code

ITI

Product Code Name

Wheelchair, Powered

Public Device Record Key

0d486979-1a53-4e1b-a95e-fb2961c422c3

Public Version Date

August 13, 2021

Public Version Number

2

DI Record Publish Date

March 18, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-