Contra Angle 16:1 Endodontics - Contra Angle 16:1 Endodontics - Nouvag AG

Duns Number:480610476

Device Description: Contra Angle 16:1 Endodontics

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More Product Details

Catalog Number

-

Brand Name

Contra Angle 16:1 Endodontics

Version/Model Number

5061NOU

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K022505

Product Code Details

Product Code

EGS

Product Code Name

Handpiece, Contra- And Right-Angle Attachment, Dental

Device Record Status

Public Device Record Key

ba8b9720-37bc-4248-86e5-24d4fda1fac3

Public Version Date

September 21, 2018

Public Version Number

1

DI Record Publish Date

August 21, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NOUVAG AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 72
2 A medical device with a moderate to high risk that requires special controls. 95