Catalog Number

USFRACTA

Brand Name

SYMMETRY

Version/Model Number

USFRACTA

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 19, 2022

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

K053178

Product Code

ELC

Product Code Name

Scaler, ultrasonic

Public Device Record Key

5b2ea3d9-7db0-4925-8194-7618a7868c26

Public Version Date

January 20, 2022

Public Version Number

3

DI Record Publish Date

September 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-