Catalog Number

000113

Brand Name

GC Fuji II®

Version/Model Number

000113

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K880848,K880848,K880848

Product Code

EMA

Product Code Name

CEMENT, DENTAL

Public Device Record Key

168bc617-2237-4505-adc7-28b5d72fc0a1

Public Version Date

August 29, 2022

Public Version Number

1

DI Record Publish Date

August 19, 2022

Package DI Number

24548161329399

Quantity per Package

5

Contains DI Package

14548161329392

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton