Megadyne - E-Z Clean, PTFE Coated, Electrosurgical - MEGADYNE MEDICAL PRODUCTS, INC.

Duns Number:185444825

Device Description: E-Z Clean, PTFE Coated, Electrosurgical Laparoscopic Electrode, L-Wire 33 cm., Single-Use, E-Z Clean, PTFE Coated, Electrosurgical Laparoscopic Electrode, L-Wire 33 cm., Single-Use, for use with hand control pencil

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More Product Details

Catalog Number

-

Brand Name

Megadyne

Version/Model Number

0100J

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2021

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

K913281,K913281

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Device Record Status

Public Device Record Key

44ec763f-eb14-4334-8980-524e6e8a00e4

Public Version Date

December 31, 2021

Public Version Number

5

DI Record Publish Date

September 04, 2018

Additional Identifiers

Package DI Number

30614559105850

Quantity per Package

6

Contains DI Package

10614559105856

Package Discontinue Date

December 31, 2021

Package Status

Not in Commercial Distribution

Package Type

-

"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