Catalog Number

9630-1

Brand Name

Invacare I-Class All-In-One Commode - Single Pack

Version/Model Number

9630-1

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

INN

Product Code Name

CHAIR, ADJUSTABLE, MECHANICAL

Public Device Record Key

17536d93-c924-42b3-aaf1-84124347f980

Public Version Date

June 18, 2019

Public Version Number

1

DI Record Publish Date

June 10, 2019

Package DI Number

10841447102400

Quantity per Package

4

Contains DI Package

00841447102403

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACKAGE