Catalog Number

-

Brand Name

N.A.

Version/Model Number

274-298-60

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

Yes

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

K011425

Product Code

EIH

Product Code Name

POWDER, PORCELAIN

Public Device Record Key

b4d831c0-8b56-4bcb-b68c-1214dd5926e5

Public Version Date

July 24, 2018

Public Version Number

4

DI Record Publish Date

September 01, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-