Catalog Number

431012

Brand Name

GC Fuji PLUS®

Version/Model Number

431012

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

-

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

K946100,K946100

Product Code

EMA

Product Code Name

CEMENT, DENTAL

Public Device Record Key

c5ef89f2-78de-4bfd-ae11-a47ded19b7fb

Public Version Date

July 21, 2022

Public Version Number

1

DI Record Publish Date

July 13, 2022

Package DI Number

20386040009147

Quantity per Package

5

Contains DI Package

10386040009140

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton