Catalog Number

000021

Brand Name

GC Fuji LINING™

Version/Model Number

000021

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

-

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

K901999,K901999

Product Code

EJK

Product Code Name

LINER, CAVITY, CALCIUM HYDROXIDE

Public Device Record Key

7d8fc475-e5b0-4f50-b0e6-b24700e2d3bd

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 01, 2016

Package DI Number

D0470000212

Quantity per Package

5

Contains DI Package

D0470000211

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton