Catalog Number

130945

Brand Name

A.S.A.P.® Indirect+ Extraoral/HP Disc Adjuster Refill

Version/Model Number

130945

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EHJ

Product Code Name

DISK, ABRASIVE

Public Device Record Key

dd5ca6d3-19b9-4f7c-96bd-8647e6781b9b

Public Version Date

March 23, 2020

Public Version Number

3

DI Record Publish Date

June 05, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-