Catalog Number

-

Brand Name

Focus Cap Array

Version/Model Number

100-7012-055

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

-

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

K121346,K133364,K140719,K143105,K121346,K133364,K140719,K143105

Product Code

GEX

Product Code Name

Powered laser surgical instrument

Public Device Record Key

845ba25d-0b17-44b6-91b6-84a6d4e1f44d

Public Version Date

February 06, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

10841494100022

Quantity per Package

3

Contains DI Package

00841494100025

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box