Catalog Number

-

Brand Name

EL-FORM Electroforming Liquid, 1000 ml

Version/Model Number

625010

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 07, 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

-

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

304a82a7-48d5-41d3-a34e-e717977f296b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 13, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-