Catalog Number

-

Brand Name

N/A

Version/Model Number

VCRUL222-V

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

K132368,K132368

Product Code

NJM

Product Code Name

Bracket, Ceramic, Orthodontic

Public Device Record Key

444d08c3-c6d6-456d-91ba-6400d38a4a4a

Public Version Date

June 03, 2020

Public Version Number

1

DI Record Publish Date

May 26, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-