Catalog Number

-

Brand Name

Carrera Loop Electrodes

Version/Model Number

OCMR-1512

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K982739,K982739

Product Code

HGI

Product Code Name

Electrocautery, Gynecologic (And Accessories)

Public Device Record Key

20195e2a-55f9-4022-870f-cb348e556e7c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 19, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-