Catalog Number

-

Brand Name

SONICBEAT 5 mm, 45 cm, Front-actuated Grip

Version/Model Number

SB-0545FC

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

Yes

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

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

ea46a4a7-8b00-4251-af6f-c0176842e884

Public Version Date

December 09, 2021

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

14953170370578

Quantity per Package

5

Contains DI Package

04953170370571

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-