Catalog Number

-

Brand Name

FRONT LOADING SUPER-LOOP ELEC (BOX OF 5)

Version/Model Number

784415

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

K031085,K031085

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

97c21699-0353-4383-b53b-4f942f8e4fe3

Public Version Date

February 07, 2019

Public Version Number

5

DI Record Publish Date

October 04, 2016

Package DI Number

00821925011335

Quantity per Package

5

Contains DI Package

00821925039506

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-