Catalog Number

0855C

Brand Name

Megadyne

Version/Model Number

RS271A30

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

-

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

2f91d27d-6a79-4981-9ff9-2d2d4b906989

Public Version Date

August 11, 2020

Public Version Number

3

DI Record Publish Date

March 18, 2020

Package DI Number

29005531507771

Quantity per Package

50

Contains DI Package

19005531507774

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box