GC Fuji® - GC Fuji® Automix LC Set- Cartridge A1 shade + 20 - Gc America Inc.

Duns Number:005473608

Device Description: GC Fuji® Automix LC Set- Cartridge A1 shade + 20 Automix tips

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

012712

Brand Name

GC Fuji®

Version/Model Number

012712

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

-

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

K172382

Product Code Details

Product Code

EMA

Product Code Name

CEMENT, DENTAL

Device Record Status

Public Device Record Key

06eb0221-6d65-4494-af4a-78bc9aab19d1

Public Version Date

August 15, 2022

Public Version Number

1

DI Record Publish Date

August 05, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GC AMERICA INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 480
2 A medical device with a moderate to high risk that requires special controls. 4772