Catalog Number

-

Brand Name

Wenzellite

Version/Model Number

FC 8000N

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KNO

Product Code Name

ACCESSORIES, WHEELCHAIR

Public Device Record Key

5d95838c-0cb3-43c5-aac0-cbfe7c9ecc09

Public Version Date

February 10, 2020

Public Version Number

1

DI Record Publish Date

February 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-