Catalog Number

876427

Brand Name

GC Initial™

Version/Model Number

876427

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

K040567

Product Code

EIH

Product Code Name

POWDER, PORCELAIN

Public Device Record Key

c44fbd3e-d9af-4736-8698-1e30b371f3cc

Public Version Date

August 08, 2022

Public Version Number

1

DI Record Publish Date

July 29, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-