Catalog Number

-

Brand Name

MARCO

Version/Model Number

MARCO AT-8 APPLANATION TONOMETER

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

K182491

Product Code

HKY

Product Code Name

Tonometer, Manual

Public Device Record Key

ba17e94b-1e26-4977-ba11-b142226c8c69

Public Version Date

February 25, 2019

Public Version Number

1

DI Record Publish Date

January 23, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-