Catalog Number

-

Brand Name

McKesson

Version/Model Number

146-K320ADDA-SF

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"

Yes

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

K082784

Product Code

IOR

Product Code Name

Wheelchair, Mechanical

Public Device Record Key

3901659f-8eeb-42fa-8b2f-4e0ca3a91091

Public Version Date

September 26, 2019

Public Version Number

1

DI Record Publish Date

September 18, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-