Megadyne - Megadyne Telescoping Smoke Evacuation Soft Tissue - MEGADYNE MEDICAL PRODUCTS, INC.

Duns Number:185444825

Device Description: Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector

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More Product Details

Catalog Number

ME7251ST

Brand Name

Megadyne

Version/Model Number

ME7251ST

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K200253,K200253,K200253

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Device Record Status

Public Device Record Key

6e8df7ba-d3d9-4fbb-81f1-03c2ab90e8ca

Public Version Date

June 11, 2021

Public Version Number

6

DI Record Publish Date

August 03, 2020

Additional Identifiers

Package DI Number

50614559105953

Quantity per Package

60

Contains DI Package

10614559105955

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"MEGADYNE MEDICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 219