Catalog Number

-

Brand Name

Alcon, Coherent

Version/Model Number

8065010219

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

HQB

Product Code Name

Photocoagulator and accessories

Public Device Record Key

c921b541-f27c-4e05-9e40-19ce194d7fba

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

10380650102192

Quantity per Package

6

Contains DI Package

00380650102195

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box