SonicFill 3 - Sonic-Activated, Single-Fill Composite; Intro Kit - Kerr Corporation

Duns Number:199354556

Device Description: Sonic-Activated, Single-Fill Composite; Intro Kit

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More Product Details

Catalog Number

-

Brand Name

SonicFill 3

Version/Model Number

36710

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

EBC

Product Code Name

Sealant, Pit And Fissure, And Conditioner

Device Record Status

Public Device Record Key

b037fb3b-0156-49c5-938e-495e6a09fee6

Public Version Date

February 15, 2021

Public Version Number

3

DI Record Publish Date

July 27, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KERR CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 98
2 A medical device with a moderate to high risk that requires special controls. 595
U Unclassified 5