Catalog Number

-

Brand Name

East Coast Surgical Instruments

Version/Model Number

14-8300CRV

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KNF

Product Code Name

Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)

Public Device Record Key

0f4b863a-ece9-46c8-a5af-08296f979141

Public Version Date

February 21, 2019

Public Version Number

3

DI Record Publish Date

August 24, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-