Catalog Number

-

Brand Name

OPTILASA

Version/Model Number

OP-1S

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K023676

Product Code

HKX

Product Code Name

Tonometer, Ac-Powered

Public Device Record Key

b55d55a7-9f6b-443e-96f5-e5f0e55419d6

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 26, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-