Catalog Number

-

Brand Name

Eco-Cut - Single Use Inserts

Version/Model Number

ECO-100

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

K063485,K063485

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

59aa5488-6290-4be0-abd7-f6f4d0bebfa0

Public Version Date

October 16, 2020

Public Version Number

1

DI Record Publish Date

October 08, 2020

Package DI Number

05051986012568

Quantity per Package

10

Contains DI Package

05051986012551

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-