Catalog Number

56333

Brand Name

JCH-2

Version/Model Number

JCH-2

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EKX

Product Code Name

HANDPIECE, DIRECT DRIVE, AC-POWERED

Public Device Record Key

5f903b89-6811-46bd-87cc-27a715ecccea

Public Version Date

August 09, 2019

Public Version Number

3

DI Record Publish Date

June 07, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-