Catalog Number

R121

Brand Name

PDT, Inc.

Version/Model Number

R121 MacFarlane 0-1

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

EMN

Product Code Name

Scaler, Periodontic

Public Device Record Key

bf7b2b98-64b8-48a0-aa81-2ba38e9c28f6

Public Version Date

May 18, 2022

Public Version Number

2

DI Record Publish Date

April 30, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-