Catalog Number

0440

Brand Name

Megadyne

Version/Model Number

0440

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

K925478,K925478,K925478

Product Code

HGI

Product Code Name

ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)

Public Device Record Key

d505d35f-5428-458a-a96d-600c05df6669

Public Version Date

April 27, 2022

Public Version Number

12

DI Record Publish Date

December 11, 2016

Package DI Number

50614559101177

Quantity per Package

180

Contains DI Package

10614559101179

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE