Jiffy Natural Composite - Jiffy RA Asst Natural Composite 14mm Wheel 6pk - ULTRADENT PRODUCTS, INC.

Duns Number:013369913

Device Description: Jiffy RA Asst Natural Composite 14mm Wheel 6pk

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More Product Details

Catalog Number

6109

Brand Name

Jiffy Natural Composite

Version/Model Number

6109

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

6c3287e8-87d4-47a6-9cfa-26fb697e5dae

Public Version Date

March 23, 2020

Public Version Number

3

DI Record Publish Date

March 16, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ULTRADENT PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 450
2 A medical device with a moderate to high risk that requires special controls. 631
U Unclassified 18