Catalog Number

SE79B

Brand Name

Greenwald Surgical Company, Inc.

Version/Model Number

25102-00

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

-

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

bdf6cb3e-9ca3-4afc-b510-fb094cfe4854

Public Version Date

July 18, 2018

Public Version Number

3

DI Record Publish Date

September 29, 2016

Package DI Number

10801334014063

Quantity per Package

5

Contains DI Package

10801334011475

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-