Catalog Number

SIEC-DJX/1

Brand Name

Bipolar Cable

Version/Model Number

SIEC-DJX/1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K190336,K190336

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

47303897-f5ab-4396-96c0-99e878cdffd2

Public Version Date

April 06, 2021

Public Version Number

1

DI Record Publish Date

March 29, 2021

Package DI Number

00810026181511

Quantity per Package

19

Contains DI Package

00810026181757

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case