Catalog Number

ASM-20018-04

Brand Name

Propel

Version/Model Number

ASM-20018-04

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 15, 2019

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ECR

Product Code Name

Setter, Band, Orthodontic

Public Device Record Key

0958cc5d-9af9-44fc-bb5d-10a108676728

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

March 09, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-