Catalog Number

012834

Brand Name

GC Initial™

Version/Model Number

012834

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

0b2a7c20-a369-44cd-a513-934ecece58b2

Public Version Date

August 05, 2021

Public Version Number

1

DI Record Publish Date

July 28, 2021

Package DI Number

D0470128344

Quantity per Package

15

Contains DI Package

D0470128341

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton