Catalog Number

-

Brand Name

FMAT1 Prism B

Version/Model Number

Prism B

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

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

-

Product Code

HKY

Product Code Name

Tonometer, Manual

Public Device Record Key

a928615e-55c4-4146-9cab-e1fc95a18d80

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 08, 2016

Package DI Number

10867009000212

Quantity per Package

250

Contains DI Package

00867009000215

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack