Catalog Number

R696

Brand Name

PDT, Inc.

Version/Model Number

R696 Gracey 13-14 Titanium Extended Reach Micro Mini

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

EMS

Product Code Name

Curette, Periodontic

Public Device Record Key

9e4585b6-5e2d-4098-aa2f-07ce08aae7aa

Public Version Date

May 17, 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

-