Catalog Number

01050022

Brand Name

Pontor 2

Version/Model Number

01050022_1OZ

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 24, 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

EJT

Product Code Name

Alloy, Gold-Based Noble Metal

Public Device Record Key

2d974841-c8c6-46e2-90b5-111adcc78d7a

Public Version Date

April 30, 2021

Public Version Number

3

DI Record Publish Date

April 14, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-