Young - Young Zooby DPA, Latex Free, Soft, Short, Web - YOUNG DENTAL MANUFACTURING I, LLC

Duns Number:006309355

Device Description: Young Zooby DPA, Latex Free, Soft, Short, Web Cup, Assorted Zoo Animal Prophy Angles, Samp Young Zooby DPA, Latex Free, Soft, Short, Web Cup, Assorted Zoo Animal Prophy Angles, Sample 5-Pack

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More Product Details

Catalog Number

999200

Brand Name

Young

Version/Model Number

999200

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

Yes

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

EGS

Product Code Name

Handpiece, contra- and right-angle attachment, dental

Device Record Status

Public Device Record Key

eee72a2a-3bcf-43ed-b169-e4cdb09e22cb

Public Version Date

October 24, 2022

Public Version Number

1

DI Record Publish Date

October 16, 2022

Additional Identifiers

Package DI Number

10302739992005

Quantity per Package

1

Contains DI Package

00302739992008

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Package

"YOUNG DENTAL MANUFACTURING I, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 138
2 A medical device with a moderate to high risk that requires special controls. 85