Catalog Number

-

Brand Name

Smith and Nephew

Version/Model Number

EICA9820-01

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)

Yes

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

K172647,K172647,K172647

Product Code

NUJ

Product Code Name

Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

Public Device Record Key

656e66ef-8a75-4f44-a2b8-01319df8d0eb

Public Version Date

March 01, 2021

Public Version Number

5

DI Record Publish Date

December 13, 2019

Package DI Number

10810041632460

Quantity per Package

1

Contains DI Package

00810041632463

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box