Catalog Number

-

Brand Name

amda®

Version/Model Number

607-182-07

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

DYJ

Product Code Name

RETAINER, SCREW EXPANSION, ORTHODONTIC

Public Device Record Key

36a4bb2f-aaaa-42fe-bfbc-b2c84c38b572

Public Version Date

November 16, 2021

Public Version Number

5

DI Record Publish Date

September 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-