Catalog Number

133-1202

Brand Name

Sonus

Version/Model Number

M 2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K811396

Product Code

ELC

Product Code Name

Scaler, Ultrasonic

Public Device Record Key

45bbb691-c133-48d4-9054-ec4832125840

Public Version Date

May 12, 2021

Public Version Number

1

DI Record Publish Date

May 04, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-