CHAIRSIDE - CHAIRSIDE Polisher Bur, 5 Pack - Zest Anchors, LLC

Duns Number:078387192

Device Description: CHAIRSIDE Polisher Bur, 5 Pack

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More Product Details

Catalog Number

-

Brand Name

CHAIRSIDE

Version/Model Number

09580

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

EJQ

Product Code Name

WHEEL, POLISHING AGENT

Device Record Status

Public Device Record Key

c34df9d3-4531-40f4-8469-c83b7fd05d02

Public Version Date

July 18, 2022

Public Version Number

1

DI Record Publish Date

July 08, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZEST ANCHORS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 398
2 A medical device with a moderate to high risk that requires special controls. 2802