Catalog Number

790-203-535

Brand Name

SurgyCut

Version/Model Number

790-203-535

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

-

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

4f6a425c-d3b1-430e-a3f9-8b5353abd52b

Public Version Date

July 25, 2022

Public Version Number

2

DI Record Publish Date

March 20, 2019

Package DI Number

00810014631936

Quantity per Package

100

Contains DI Package

00810014631912

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box