AccessGUDID - DEVICE: Megadyne (10614559100646)

GUDID

Device Identifier (DI) Information

Brand Name: Megadyne
Version or Model: 0080
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEGADYNE MEDICAL PRODUCTS, INC.

Primary DI Number: 10614559100646
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 185444825 *Terms of Use

Device Description: 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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation 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
No Device Sizes

Device Record Status

Public Device Record Key: 040a21b0-a576-4f7a-8207-25f74b5f1e2d
Public Version Date: April 04, 2023
Public Version Number: 8
DI Record Publish Date: December 08, 2016