Catalog Number

-

Brand Name

SurgyCut

Version/Model Number

790-125-535

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

7dfafb21-cb96-409d-84f0-85203d79c7ff

Public Version Date

December 31, 2019

Public Version Number

1

DI Record Publish Date

December 23, 2019

Package DI Number

00810014631752

Quantity per Package

100

Contains DI Package

00810014631745

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-