Catalog Number

-

Brand Name

Ultrasonic Tips

Version/Model Number

973-0112

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K934714

Product Code

ELC

Product Code Name

Scaler, Ultrasonic

Public Device Record Key

778cedd9-fad8-4ce5-96ff-4939dce9e306

Public Version Date

March 15, 2021

Public Version Number

1

DI Record Publish Date

March 05, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-