Catalog Number

874546

Brand Name

GC Initial™

Version/Model Number

874546

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 10, 2017

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

K040567

Product Code

EIH

Product Code Name

POWDER, PORCELAIN

Public Device Record Key

64ec0d1e-6590-429f-9c00-c6efd8e84416

Public Version Date

July 24, 2018

Public Version Number

4

DI Record Publish Date

August 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-