Megadyne

GUDID 30614559102170

Stainless Steel, Electrosurgical Laparoscopic Electrode with Indicator, Curved Spatula, 32 cm., Reusable, For Use With Hand Control Pencil

MEGADYNE MEDICAL PRODUCTS, INC.

Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator
Primary Device ID30614559102170
NIH Device Record Keyc57ec7ba-58df-4a7b-b935-5f7fe706486a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMegadyne
Version Model Number3018
Company DUNS185444825
Company NameMEGADYNE MEDICAL PRODUCTS, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com

Operating and Storage Conditions

Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110614559102176 [Primary]
GS110614559102176 [Primary]
GS110614559102176 [Primary]
GS110614559102176 [Primary]
GS110614559102176 [Primary]
GS110614559102176 [Primary]
GS110614559102176 [Primary]
GS110614559102176 [Primary]
GS110614559102176 [Primary]
GS110614559102176 [Primary]
GS110614559102176 [Primary]
GS110614559102176 [Primary]
GS110614559102176 [Primary]
GS110614559102176 [Primary]
GS130614559102170 [Package]
Contains: 10614559102176
Package: [2 Units]
In Commercial Distribution
GS130614559102170 [Package]
Contains: 10614559102176
Package: [2 Units]
In Commercial Distribution
GS130614559102170 [Package]
Contains: 10614559102176
Package: [2 Units]
In Commercial Distribution
GS130614559102170 [Package]
Contains: 10614559102176
Package: [2 Units]
In Commercial Distribution
GS130614559102170 [Package]
Contains: 10614559102176
Package: [2 Units]
In Commercial Distribution
GS130614559102170 [Package]
Contains: 10614559102176
Package: [2 Units]
In Commercial Distribution
GS130614559102170 [Package]
Contains: 10614559102176
Package: [2 Units]
In Commercial Distribution
GS130614559102170 [Package]
Contains: 10614559102176
Package: [2 Units]
In Commercial Distribution
GS130614559102170 [Package]
Contains: 10614559102176
Package: [2 Units]
In Commercial Distribution
GS130614559102170 [Package]
Contains: 10614559102176
Package: [2 Units]
In Commercial Distribution
GS130614559102170 [Package]
Contains: 10614559102176
Package: [2 Units]
In Commercial Distribution
GS130614559102170 [Package]
Contains: 10614559102176
Package: [2 Units]
In Commercial Distribution
GS130614559102170 [Package]
Contains: 10614559102176
Package: [2 Units]
In Commercial Distribution
GS130614559102170 [Package]
Contains: 10614559102176
Package: [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[30614559102170]

Moist Heat or Steam Sterilization


[30614559102170]

Moist Heat or Steam Sterilization


[30614559102170]

Moist Heat or Steam Sterilization


[30614559102170]

Moist Heat or Steam Sterilization


[30614559102170]

Moist Heat or Steam Sterilization


[30614559102170]

Moist Heat or Steam Sterilization


[30614559102170]

Moist Heat or Steam Sterilization


[30614559102170]

Moist Heat or Steam Sterilization


[30614559102170]

Moist Heat or Steam Sterilization


[30614559102170]

Moist Heat or Steam Sterilization


[30614559102170]

Moist Heat or Steam Sterilization


[30614559102170]

Moist Heat or Steam Sterilization


[30614559102170]

Moist Heat or Steam Sterilization


[30614559102170]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-09-16
Device Publish Date2016-12-14

On-Brand Devices [Megadyne]

10614559105405Connector Smoke Evacuator Universal Non-sterile
10614559105399Connector 22mm ID Filter to Tubing Non-sterile
10614559105382Mega Vac Connector Filter to Tubing Non-sterile
30614559104648Megadyne Smoke Evacuator RF Sensor
30614559103009Ultra Vac Smoke Evacuation Pencil, Telescopic, Stainless Electrode, 9 Ft (2.74m) Tubing
30614559102996Smoke Evacuation Pencil, Telescopic, Stainless Electrode, , 22mm Connector, 9 Ft (2.74m) Tubing
10614559102060Connector, Smoke Evacuator to Tubing, 22mm I.D., non-sterile
10614559102053Connector Smoke Evacuator Universal Non-sterile
10614559102046Connector 22mm ID Filter to Tubing Non-sterile
10614559102039Mega Vac Connector Filter to Tubing Non-sterile
30614559104518E-Z Clean, Non-stick, PTFE Coated, Electrosurgical Blade Electrode, 4.72 inch (12 cm), Custom
50614559103591Electrosurgical Pencil Rocker Switch E-Z Clean Coated Blade Electrode 15 foot (4.6 m) Cord Bulk
50614559103553Electrosurgical Pencil Button Switch E-Z Clean Coated Blade Electrode 15 foot (4.6 m) Cord Bulk
10614559103890Reusable Patient Return Electrode Cable, Single Plate, 3m (10 ft)
30614559100879Patient Return Electrode, Single-Use, non Contact Quality Monitoring, Adult, Without Cord, For P
30614559100855Electrosurgical Pencil Button Switch Non Coated Blade Electrode 10 ft (3 m) cord
30614559100831Electrosurgical Pencil Rocker Switch Non Coated Blade Electrode 10 ft (3 m) cord
30614559104631ZIP Pen Ergonomic Smoke Evacuation Pencil, E-Z Clean, Non-Stick, PTFE Coated, 10 Ft (3.04m) Tub
30614559102934Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)
30614559102927Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm)
30614559102910Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)
30614559102903Suction Coagulator, Footswitching, 10 Fr, 6 inch (15.24cm)
10614559102886Mega Power Cart, unassembled, no top shelf
10614559102879Mega Power Cart with Top Shelf
30614559102798Suction Coagulator, Footswitching, 10 Fr, 6 inch (15.24cm)
30614559104143E-Z Clean, Non-stick, PTFE Coated, Precision Blade Electrode, Modified Insulation, 2.5 in (6.4 c
10614559104507Mother Board Subassembly, Motherboard Updated ROHS Faceplate, For Mega Power Generator, R
10614559104170Mother Board Subassembly, Motherboard Updated Faceplate, For Mega Power Generator, R
10614559103968Mother Board Subassembly, Motherboard Original Faceplate, R
30614559102323Stainless Steel, Electrosurgical Laparoscopic Electrode with Indicator, J-Hook, 38 cm., Reusable
30614559102316Stainless Steel, Electrosurgical Laparoscopic Electrode with Indicator, J-Hook, 38 cm., Reusable
30614559102309Stainless Steel, Electrosurgical Laparoscopic Electrode with Indicator, J-Hook, 32 cm., Reusable
30614559102293Stainless Steel, Electrosurgical Laparoscopic Electrode with Indicator, J-Hook, 32 cm., Reusable
30614559102286Stainless Steel, Electrosurgical Laparoscopic Electrode with Indicator, L-Hook, Long, 38 cm., Re
30614559102279Stainless Steel, Electrosurgical Laparoscopic Electrode with Indicator, L-Hook, Long, 38 cm., Re
30614559102248Stainless Steel, Electrosurgical Laparoscopic Electrode with Indicator, Spatula, Long, 38 cm., R
30614559102231Stainless Steel, Electrosurgical Laparoscopic Electrode with Indicator, Spatula, Long, 38 cm., R
30614559105966Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Modified
30614559105959Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector
30614559105942Megadyne Telescoping Soft Tissue Dissector, Modified
30614559105935Megadyne Telescoping Soft Tissue Dissector
30614559105584Megadyne Telescoping Smoke Evacuation Pencil - 15 ft tubing with Universal Connector and Holster
30614559105577Megadyne Telescoping Smoke Evacuation Pencil - 10 ft tubing with Universal Connector and Holster
10614559104668Megadyne Smoke Evacuator Connect Cable, 2.1m
10614559104651Megadyne Smoke Evacuator Connect Cable, 1m
10614559104552Megadyne MESE1 Smoke Evacuator Filter
10614559104545Megadyne Smoke Evacuator
30614559101289E-Z Clean, Non-stick, PTFE Coated, Electrosurgical Blade Electrode, 2.5 inch, 6.35 cm, Single-Us
30614559101418E-Z Clean, Non-stick, PTFE Coated, Mega Fine Electrosurgical Needle Electrode, Sharp, 2.5 inch (
30614559100701Non Coated Electrosurgical Ball Electrode, 5 inch (12.7cm)

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