Catalog Number

-

Brand Name

POTENZA Tip

Version/Model Number

S-25 Tip

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

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

K201685,K201685

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

70fe0472-5bca-4da0-aab4-5e1c83f8608a

Public Version Date

March 31, 2022

Public Version Number

2

DI Record Publish Date

April 02, 2021

Package DI Number

18800020100266

Quantity per Package

5

Contains DI Package

08800020100269

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON BOX