Catalog Number

0009

Brand Name

Megadyne

Version/Model Number

0009

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

K081791,K862221,K081791,K862221,K081791,K862221

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

9b35ca37-f338-4ce8-bc4a-40dbed9b42af

Public Version Date

June 11, 2021

Public Version Number

10

DI Record Publish Date

December 01, 2016

Package DI Number

50614559100040

Quantity per Package

132

Contains DI Package

10614559100042

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE