Catalog Number

-

Brand Name

NA

Version/Model Number

A202000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

Yes

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

K142830,K142830

Product Code

HQB

Product Code Name

Photocoagulator And Accessories

Public Device Record Key

4fd754f2-12bc-404b-85e6-02a9963c0803

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

M735A2020005

Quantity per Package

10

Contains DI Package

M735A2020001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-