Catalog Number

000114

Brand Name

GC Fuji II LC®

Version/Model Number

000114

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

EMA

Product Code Name

CEMENT, DENTAL

Public Device Record Key

9c9188e8-b352-48fa-b6fd-303cf32c983d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 01, 2016

Package DI Number

D0470001142

Quantity per Package

5

Contains DI Package

D0470001141

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton