FitStrip™ - Strip Refill, Double-Sided, Medium Grit, Blue: 10 - GARRISON DENTAL SOLUTIONS, L.L.C.

Duns Number:057647005

Device Description: Strip Refill, Double-Sided, Medium Grit, Blue: 10 Strips, 2 Handles

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More Product Details

Catalog Number

FPSMDS

Brand Name

FitStrip™

Version/Model Number

FPSMDS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

DZP

Product Code Name

Instrument, Diamond, Dental

Device Record Status

Public Device Record Key

11ebe35f-cec9-47e7-b209-eb2d87a0543a

Public Version Date

May 04, 2020

Public Version Number

1

DI Record Publish Date

April 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GARRISON DENTAL SOLUTIONS, L.L.C." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 436