Catalog Number

78-A3U0-1925

Brand Name

Stainless Steel

Version/Model Number

78-A3U0-1925

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

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

-

Product Code

EJF

Product Code Name

BRACKET, METAL, ORTHODONTIC

Public Device Record Key

33081a98-46ed-4a02-8d34-10eb050fb19b

Public Version Date

August 23, 2021

Public Version Number

1

DI Record Publish Date

August 14, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-