Catalog Number

-

Brand Name

NOBILIUM

Version/Model Number

I8134

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 17, 2016

Issuing Agency

In HIBCC

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

K033020

Product Code

EBI

Product Code Name

Resin, Denture, Relining, Repairing, Rebasing

Public Device Record Key

34d22ca4-c2d3-4cb7-a2ea-07be8fcb732e

Public Version Date

November 10, 2021

Public Version Number

5

DI Record Publish Date

February 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-