Catalog Number

-

Brand Name

CERABIEN™ MiLai

Version/Model Number

109-0292KA

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

K213147

Product Code

EIH

Product Code Name

Powder, Porcelain

Public Device Record Key

2f5de4c5-35ac-4c63-9fc1-69a789222a44

Public Version Date

May 30, 2022

Public Version Number

1

DI Record Publish Date

May 20, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-