Catalog Number

-

Brand Name

POTENZA Tip

Version/Model Number

I-16 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

7febe235-2f48-42a3-ab7a-7fbde81511da

Public Version Date

April 06, 2022

Public Version Number

1

DI Record Publish Date

March 29, 2022

Package DI Number

18800020101188

Quantity per Package

5

Contains DI Package

08800020101181

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON BOX