Catalog Number

-

Brand Name

BAOT

Version/Model Number

JC E-1B 5g

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

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

K182350

Product Code

EIH

Product Code Name

Powder, Porcelain

Public Device Record Key

2accc4ea-4425-418b-9e31-537be09dc2ff

Public Version Date

March 29, 2021

Public Version Number

1

DI Record Publish Date

March 20, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-