Sample, DPA, Vera - Classic & Contra, 6ct - Sample, DPA, Vera - Classic & Contra, 6ct - YOUNG DENTAL MANUFACTURING I, LLC

Duns Number:006309355

Device Description: Sample, DPA, Vera - Classic & Contra, 6ct

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More Product Details

Catalog Number

295833

Brand Name

Sample, DPA, Vera - Classic & Contra, 6ct

Version/Model Number

295833

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"

Yes

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

6482589c-86f4-43e6-bf04-e5a261bb7ac2

Public Version Date

October 05, 2022

Public Version Number

3

DI Record Publish Date

November 06, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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