Catalog Number

FPSGXFSS

Brand Name

FitStrip™

Version/Model Number

FPSGXFSS

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

4193c104-1e89-42cf-9abf-3ba1b48e7afb

Public Version Date

February 03, 2021

Public Version Number

1

DI Record Publish Date

January 26, 2021

Package DI Number

10810038096541

Quantity per Package

4

Contains DI Package

00810038096513

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

FPSGXFSS-4