Catalog Number

-

Brand Name

Extended Blade 6" (15.24cm) Standard

Version/Model Number

568620

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

K942986,K942986

Product Code

HGI

Product Code Name

ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)

Public Device Record Key

2e95f618-fa5f-4f31-9416-6ff9fe08496b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 03, 2016

Package DI Number

00821925010543

Quantity per Package

25

Contains DI Package

00821925041653

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-