ProMark - ProMark Foot Pedal - TULSA DENTAL PRODUCTS LLC

Duns Number:942778564

Device Description: ProMark Foot Pedal

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


More Product Details

Catalog Number

PMKEM1PDL

Brand Name

ProMark

Version/Model Number

PMKEM1PDL

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

-

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

EKX

Product Code Name

Handpiece, direct drive, ac-powered

Device Record Status

Public Device Record Key

64b4da04-95ce-47a8-9bb7-2dec78f05708

Public Version Date

September 19, 2022

Public Version Number

1

DI Record Publish Date

September 09, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TULSA DENTAL PRODUCTS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1973
2 A medical device with a moderate to high risk that requires special controls. 35
U Unclassified 16