Tria-shine 40 µm - Polydentia SA

Duns Number:481461598

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Tria-shine 40 µm

Version/Model Number

5505

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

Yes

Prescription Use (Rx)

-

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

EHL

Product Code Name

Point, Abrasive

Device Record Status

Public Device Record Key

2f9e25d1-f759-40b1-a571-79bfc52d1e8f

Public Version Date

July 13, 2022

Public Version Number

1

DI Record Publish Date

July 05, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"POLYDENTIA SA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 229
2 A medical device with a moderate to high risk that requires special controls. 13