Catalog Number

5B40S

Brand Name

Prosurg

Version/Model Number

5B40S

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

K962593,K962593

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

c9f384b9-e628-420a-8bd2-114bbf499bba

Public Version Date

May 29, 2020

Public Version Number

1

DI Record Publish Date

May 21, 2020

Package DI Number

10851545007422

Quantity per Package

5

Contains DI Package

00851545007425

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pak