Catalog Number

NA1194604

Brand Name

Laser Ceramic White

Version/Model Number

NA1194604

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 22, 2021

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

067e277a-b460-4a94-aed8-1f2a14751947

Public Version Date

June 23, 2021

Public Version Number

2

DI Record Publish Date

October 29, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-