Catalog Number

-

Brand Name

SOLOS

Version/Model Number

GS6005

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

K913514,K913514,K913514

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

784c1fcf-8912-42fd-be43-7a36e70c547d

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

10841019112080

Quantity per Package

10

Contains DI Package

00841019112083

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-