Catalog Number

012844

Brand Name

GC Initial™

Version/Model Number

012844

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

K153136,K153136

Product Code

EIH

Product Code Name

POWDER, PORCELAIN

Public Device Record Key

dab1df25-eeb0-45cc-a6bc-18fadba0a4df

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 11, 2019

Package DI Number

D0470128444

Quantity per Package

15

Contains DI Package

D0470128441

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton