Catalog Number

-

Brand Name

AURADONICS

Version/Model Number

811-060NL

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

-

Product Code

ECI

Product Code Name

Band, Elastic, Orthodontic

Public Device Record Key

bf1cbe9c-67f6-4e56-9169-7e9ec32dc501

Public Version Date

May 10, 2021

Public Version Number

1

DI Record Publish Date

April 30, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-