Catalog Number

-

Brand Name

Icare tonometer probes

Version/Model Number

TP01s

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 01, 2016

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)

Yes

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

K063873,K153694

Product Code

HKX

Product Code Name

Tonometer, Ac-Powered

Public Device Record Key

abcb24ee-8c10-42b8-893e-17f38d8df3b9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-