Catalog Number

M2K01

Brand Name

Mega Soft

Version/Model Number

M2K01

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

-

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

K080741,K133726,K080741,K133726

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Public Device Record Key

42327055-22b2-46fc-899e-59339ca2b367

Public Version Date

June 11, 2021

Public Version Number

9

DI Record Publish Date

September 05, 2018

Package DI Number

30614559105171

Quantity per Package

40

Contains DI Package

10614559105177

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE