Catalog Number

4400200

Brand Name

Obsidian

Version/Model Number

4400200

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

K030859

Product Code

EIH

Product Code Name

POWDER, PORCELAIN

Public Device Record Key

98756976-fe8e-4abb-bde8-98b0e6d2072a

Public Version Date

July 24, 2018

Public Version Number

4

DI Record Publish Date

May 31, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-