Vivid KleenSert - IF-10 30k - PEARSON DENTAL SUPPLIES, INC.

Duns Number:082874108

Device Description: IF-10 30k

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More Product Details

Catalog Number

-

Brand Name

Vivid KleenSert

Version/Model Number

R910120

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

ELC

Product Code Name

Scaler, Ultrasonic

Device Record Status

Public Device Record Key

44c01375-7d33-4146-a92a-f20adfb47cb9

Public Version Date

February 21, 2019

Public Version Number

3

DI Record Publish Date

June 29, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PEARSON DENTAL SUPPLIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 447