Catalog Number

22885

Brand Name

NobelProcera®

Version/Model Number

22885

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 21, 2020

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EJH

Product Code Name

ALLOY, METAL, BASE

Public Device Record Key

865b3d12-80f6-452e-85a8-e3c6d116dba6

Public Version Date

April 26, 2021

Public Version Number

7

DI Record Publish Date

September 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-