Catalog Number

803EB

Brand Name

De Mayo Knee Positioner®

Version/Model Number

803EB

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

-

Product Code

FWZ

Product Code Name

Operating Room Accessories Table Tray

Public Device Record Key

7e117a6a-f653-4495-81f8-972805359e06

Public Version Date

September 20, 2019

Public Version Number

1

DI Record Publish Date

September 12, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-