Catalog Number

R009

Brand Name

PDT, Inc.

Version/Model Number

Gracey 17-18 ER Mini

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 01, 2020

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

EMS

Product Code Name

Curette, Periodontic

Public Device Record Key

94c15cac-97f5-408d-92ec-4b6d7e072847

Public Version Date

December 01, 2020

Public Version Number

2

DI Record Publish Date

September 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-