Sample, Denticator Eco Slim Snap On, DPA - Sample, Denticator Eco Slim Snap On, DPA - YOUNG DENTAL MANUFACTURING I, LLC

Duns Number:006309355

Device Description: Sample, Denticator Eco Slim Snap On, DPA

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More Product Details

Catalog Number

295489

Brand Name

Sample, Denticator Eco Slim Snap On, DPA

Version/Model Number

295489

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

deb2e27e-ff96-4c0f-b5c7-ae9409eb289e

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