Catalog Number

FPSMDS-1

Brand Name

FitStrip™

Version/Model Number

FPSMDS-1

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

-

Product Code

DZP

Product Code Name

Instrument, Diamond, Dental

Public Device Record Key

b67c98aa-41e9-42f3-8252-305c7d98749f

Public Version Date

May 04, 2020

Public Version Number

1

DI Record Publish Date

April 24, 2020

Package DI Number

10810038094066

Quantity per Package

4

Contains DI Package

00810038094069

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

FPSMDS-4