Catalog Number

-

Brand Name

OptiScan

Version/Model Number

OAM001885

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

K182669

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

ca39f9a8-2113-4e2c-965e-93ef3cfc2cb8

Public Version Date

February 07, 2019

Public Version Number

1

DI Record Publish Date

January 07, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-