Mega Soft

GUDID 10614559105238

Mega Soft Replacement Cord

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 ID10614559105238
NIH Device Record Key80a2af5d-16b1-4ffd-b26e-462af6c2504c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMega Soft
Version Model NumberM2K07
Company DUNS185444825
Company NameMEGADYNE MEDICAL PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
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
GS110614559105238 [Primary]
GS110614559105238 [Primary]
GS110614559105238 [Primary]
GS110614559105238 [Primary]
GS110614559105238 [Primary]
GS110614559105238 [Primary]
GS110614559105238 [Primary]
GS110614559105238 [Primary]
GS110614559105238 [Primary]
GS110614559105238 [Primary]
GS110614559105238 [Primary]
GS110614559105238 [Primary]
GS110614559105238 [Primary]
GS110614559105238 [Primary]

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 Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-09-16
Device Publish Date2018-09-05

On-Brand Devices [Mega Soft]

10614559101421Mega Soft Standard Cable 2.4m (8'-0")
10614559103463Mega Soft Replacement Cord
10614559103388Mega Soft Compatibility Cable 4.4 m (14'-5")
10614559103142Mega Soft Compatibility Cable 2.4 m (8'-0")
10614559101476Mega Soft Argon Beam Cable 2.4m (8'-0")
10614559101469Mega Soft Extended Phone Cable 4.4m (14'-4")
10614559101452Mega Soft Phone Cable 4.4m (14'-4")
10614559101445Mega Soft Phone Cable 2.4m (8'-0")
10614559101438Mega Soft Standard Cable 4.4m (14'-4")
10614559103395Reusable Patient Return Electrode, Mega Soft, Pediatric, For Patients weighing (0.8lb-50lb), (35
10614559103159Reusable Patient Return Electrode, Mega Soft, Pediatric, For Patients Weighing (0.8lb-50lb), (35
10614559101889Reusable Patient Return Electrode, Mega Soft, Dual Cord, Adult, For Patients Weighing over 25lbs
10614559101872Reusable Patient Return Electrode, Mega Soft, Dual Cord, Adult, For Patients Weighing over 25lbs
10614559101841Reusable Patient Return Electrode, Mega Soft, Single Cord, Adult, For Patients Weighing over 25l
10614559101797Reusable Patient Return Electrode, Mega Soft, Single Cord, Adult, For Patients Weighing over 25l
10614559105252Mega Soft Compatibility Cable 4.4 m (14'-5")
10614559105245Mega Soft Compatibility Cable 2.4 m (8'-0")
10614559105238Mega Soft Replacement Cord
10614559105221Mega Soft Argon Beam Cable 2.4m (8'-0")
10614559105214Mega Soft Extended Phone Cable 4.4m (14'-4")
10614559105207Mega Soft Phone Cable 4.4m (14'-4")
10614559105191Mega Soft Phone Cable 2.4m (8'-0")
10614559105184Mega Soft Standard Cable 4.4m (14'-4")
10614559105177Mega Soft Standard Cable 2.4m (8'-0")
10614559104255Reusable Patient Return Electrode, Mega Soft Universal Dual Cord, For Patients weighing over 0.8
10614559104248Reusable Patient Return Electrode, Mega Soft Universal Dual Cord, For Patients weighing over 0.8
10614559104026Reusable Patient Return Electrode, Mega Soft Universal, For Patients weighing over 0.8lb (350g),
10614559103906Reusable Patient Return Electrode, Mega Soft Universal, For Patients Weighing Over 0.8lb (350g),
30614559101807Mega Soft Repair Kit 4" x 36" (102mm x 915mm)

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