Catalog Number

-

Brand Name

Precision Dental Instruments

Version/Model Number

PI-9-151

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"

Yes

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

ECS

Product Code Name

Pusher, Band, Orthodontic

Public Device Record Key

58f7915c-47a3-4885-8619-32f41b45c8fe

Public Version Date

February 27, 2019

Public Version Number

1

DI Record Publish Date

January 27, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-