Brite Shield - BRITE SHIELD SAMPLE (1pk) - PREMIER DENTAL PRODUCTS COMPANY

Duns Number:014789663

Device Description: BRITE SHIELD SAMPLE (1pk)

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More Product Details

Catalog Number

-

Brand Name

Brite Shield

Version/Model Number

9011996

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FLG

Product Code Name

Cleaner, Ultrasonic, Medical Instrument

Device Record Status

Public Device Record Key

f4bf13de-a47d-4cdc-ba10-a80edbd858c8

Public Version Date

July 07, 2022

Public Version Number

1

DI Record Publish Date

June 29, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PREMIER DENTAL PRODUCTS COMPANY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 130
2 A medical device with a moderate to high risk that requires special controls. 332