Catalog Number

FPSGMSS-1

Brand Name

FitStrip™

Version/Model Number

FPSGMSS-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

d345847e-fa76-4a07-8b43-20a8baf87c9d

Public Version Date

February 03, 2021

Public Version Number

1

DI Record Publish Date

January 26, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-