NovaPro Fill - Universal Composite Carpule - White Shade - NANOVA BIO MATERIALS INC

Duns Number:006084093

Device Description: Universal Composite Carpule - White Shade

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More Product Details

Catalog Number

23118-01

Brand Name

NovaPro Fill

Version/Model Number

23118-01

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

EBF

Product Code Name

MATERIAL, TOOTH SHADE, RESIN

Device Record Status

Public Device Record Key

3c75b547-ecd3-4e92-8fc5-b56ce732c217

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

10816537020780

Quantity per Package

20

Contains DI Package

00816537020783

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"NANOVA BIO MATERIALS INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 136