DEVICE: Megadyne (10614559100646)
Device Identifier (DI) Information
Megadyne
0080
Not in Commercial Distribution
MEGADYNE MEDICAL PRODUCTS, INC.
0080
Not in Commercial Distribution
MEGADYNE MEDICAL PRODUCTS, INC.
E-Z Clean Electrosurgical 2.5 inches Electrode Blade for use with All-In-One Suction Irrigation Pencil, 5mm x 6.35cm, Single-Use
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
11490 | Electrosurgical system generator |
An electrically-powered component of a electrosurgical system intended to generate radio-frequency (RF) electrical current for subsequent cutting and coagulation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system generator). It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for inert gas-enhanced electrosurgery.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K922002 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity |
Storage Environment Temperature: between 5 and 50 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
040a21b0-a576-4f7a-8207-25f74b5f1e2d
April 04, 2023
8
December 08, 2016
April 04, 2023
8
December 08, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
30614559100640 | 5 | 10614559100646 | 2021-12-31 | Not in Commercial Distribution |
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
[?]
+18015769669
megadyne.udi@megadyne.com
megadyne.udi@megadyne.com