DEVICE: Mega Soft (10614559105214)
Device Identifier (DI) Information
Mega Soft
M2K05
In Commercial Distribution
M2K05
MEGADYNE MEDICAL PRODUCTS, INC.
M2K05
In Commercial Distribution
M2K05
MEGADYNE MEDICAL PRODUCTS, INC.
Mega Soft Extended Phone Cable 4.4m (14'-4")
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
63401 | Electrosurgical return lead |
An insulated metal wire(s) intended to connect an electrosurgical return electrode (not included) to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during monopolar electrosurgery. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GEI | Electrosurgical, cutting & coagulation & accessories |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K080741 | 000 |
K133726 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity |
Storage Environment Temperature: between 5 and 55 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
231d71b4-31fc-405c-8b29-1d4257578152
May 12, 2023
10
September 05, 2018
May 12, 2023
10
September 05, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
30614559105218 | 40 | 10614559105214 | In Commercial Distribution | CASE |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(801)576-9669
megadyne.udi@megadyne.com
megadyne.udi@megadyne.com