MEGADYNE MEDICAL PRODUCTS, INC.

Address:11506 South State Street,Draper,UT,84020,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES (GEI) (10)

Premarket Exempt

No Yes

Clear

Megadyne - 10614559100318 Catalog Number : 0020

Device Description : E-Z Clean, PTFE Coated, Electrosurgical Laparoscopic Electrode, L-Hook, 33 cm., E-Z Clean, PTFE Coated, Electrosurgical Laparoscopic Electrode, L-Hook, 33 cm., Single-Use, For Use With Hand Control Pencil

Device Class :

Duns Number: 185444825

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Megadyne - 10614559100349 Catalog Number : 0020S

Device Description : E-Z Clean, PTFE Coated, Electrosurgical Laparoscopic Electrode, L-Hook, Split St E-Z Clean, PTFE Coated, Electrosurgical Laparoscopic Electrode, L-Hook, Split Stem, 33 cm., Single-Use, For Use With Foot Control Pedal

Device Class :

Duns Number: 185444825

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Megadyne - 10614559100356 Catalog Number : 0021

Device Description : E-Z Clean, PTFE Coated, Electrosurgical Laparoscopic Electrode, J-Hook, 33 cm., E-Z Clean, PTFE Coated, Electrosurgical Laparoscopic Electrode, J-Hook, 33 cm., Single-Use, For Use With Hand Control Pencil

Device Class :

Duns Number: 185444825

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Megadyne - 10614559100387 Catalog Number : 0021S

Device Description : E-Z Clean, PTFE Coated, Electrosurgical Laparoscopic Electrode, J-Hook, Split St E-Z Clean, PTFE Coated, Electrosurgical Laparoscopic Electrode, J-Hook, Split Stem, 33 cm., Single-Use, For Use With Foot Control Pedal

Device Class :

Duns Number: 185444825

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Megadyne - 10614559100394 Catalog Number : 0022

Device Description : E-Z Clean, PTFE Coated, Electrosurgical Laparoscopic Electrode, Needle, 33 cm., E-Z Clean, PTFE Coated, Electrosurgical Laparoscopic Electrode, Needle, 33 cm., Single-Use, For Use With Hand Control Pencil

Device Class :

Duns Number: 185444825

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Megadyne - 10614559100417 Catalog Number : 0022S

Device Description : E-Z Clean, PTFE Coated, Electrosurgical Laparoscopic Electrode, Needle, Split St E-Z Clean, PTFE Coated, Electrosurgical Laparoscopic Electrode, Needle, Split Stem, 33 cm., Single-Use, For Use With Foot Control Pedal

Device Class :

Duns Number: 185444825

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Megadyne - 10614559100431 Catalog Number : 0024

Device Description : E-Z Clean, PTFE Coated, Electrosurgical Laparoscopic Electrode, Ball, 33 cm., Si E-Z Clean, PTFE Coated, Electrosurgical Laparoscopic Electrode, Ball, 33 cm., Single-Use, For Use With Hand Control Pencil

Device Class :

Duns Number: 185444825

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Megadyne - 10614559100455 Catalog Number : 0028

Device Description : E-Z Clean, Non-stick, PTFE Coated, Electrosurgical Needle Electrode, Bayonet, 6 E-Z Clean, Non-stick, PTFE Coated, Electrosurgical Needle Electrode, Bayonet, 6 inch (15.2 cm)

Device Class :

Duns Number: 185444825

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Megadyne - 10614559100462 Catalog Number : 0030

Device Description : Electrosurgical Pencil Rocker Switch E-Z Clean Coated Blade Electrode 10 ft (3 m) cord

Device Class :

Duns Number: 185444825

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Megadyne - 10614559100479 Catalog Number : 0030H

Device Description : Electrosurgical Pencil Rocker Switch E-Z Clean Coated Blade Electrode 10 ft (3 m Electrosurgical Pencil Rocker Switch E-Z Clean Coated Blade Electrode 10 ft (3 m) cord Holster

Device Class :

Duns Number: 185444825

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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