Catalog Number

000030

Brand Name

GC Fuji ORTHO™

Version/Model Number

000030

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

K981461,K981461

Product Code

DYH

Product Code Name

ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

Public Device Record Key

8c58d1e1-9323-4108-897f-d9d78792041f

Public Version Date

August 29, 2022

Public Version Number

1

DI Record Publish Date

August 19, 2022

Package DI Number

24548161283240

Quantity per Package

5

Contains DI Package

14548161283243

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton