Catalog Number

CM04SC

Brand Name

Invacare® ContourU® Vinyl Remake Seat

Version/Model Number

CM04SC

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IMP

Product Code Name

CUSHION, WHEELCHAIR

Public Device Record Key

e9cf474c-6451-4b88-98f1-fd5ce663fc7b

Public Version Date

May 10, 2021

Public Version Number

2

DI Record Publish Date

June 05, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-