Home GUDID 30614559101173 Megadyne
Primary DI 30614559101173
Brand Megadyne
Company MEGADYNE MEDICAL PRODUCTS, INC.
Model 0440
Device description LLETZ Loop Electrode, 20mm wide x 10mm deep, 11.8 cm shaft, red
Published 2016-12-11
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name GEI ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES HGI ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery 2 HGI Electrocautery, Gynecologic (And Accessories) Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 30614559101173 Package GS1 12 In Commercial Distribution 50614559101177 Package GS1 15 In Commercial Distribution 10614559101179 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 30614559101173 30614559101173 50614559101177 50614559101177 10614559101179 10614559101179
GMDN Terms# Term, Definition table Term Definition Electrosurgical system generator A mains electricity-powered (AC-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 argon-enhanced electrosurgery.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Humidity 15 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature 5 Degrees Celsius 50 Degrees Celsius
Sterilization Methods# Method table Method Radiation Sterilization
Regulatory Flags# DUNS number 185444825 Device count 1 DM exempt true Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number true Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# 
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