Home GUDID 30614559100398 Megadyne
Primary DI 30614559100398
Brand Megadyne
Company MEGADYNE MEDICAL PRODUCTS, INC.
Model 0022
Device description E-Z Clean, PTFE Coated, Electrosurgical Laparoscopic Electrode, Needle, 33 cm., Single-Use, For Use With Hand Control Pencil
Published 2016-12-06
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
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 30614559100398 Package GS1 6 In Commercial Distribution 50614559100392 Package GS1 40 In Commercial Distribution 10614559100394 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 30614559100398 30614559100398 50614559100392 50614559100392 10614559100394 10614559100394
GMDN Terms# Term, Definition table Term Definition Endoscopic electrosurgical electrode, monopolar, single-use A sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.
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 false 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# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00190776436186 Millennium Avalign Technologies, Inc. GEI 2026-10-08 00190776436544 Millenium Avalign Technologies, Inc. GEI 2026-10-08 00190776436599 Millenium Avalign Technologies, Inc. GEI 2026-10-08 00840096215380 Disposable Bipolar Forceps, 8", 1.5mm Straight Tips KATALYST SURGICAL LLC GEI 2026-10-08 00848657078504 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GEI 2026-10-08 00848657078511 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GEI 2026-10-08 00848657078528 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GEI 2026-10-08 00848657083805 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GEI 2026-10-08 00848657083904 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GEI 2026-10-08 00840096215335 Disposable Bipolar Forceps, 7", 0.5mm Straight Tips KATALYST SURGICAL LLC GEI 2026-10-07 00840096215342 Disposable Bipolar Forceps, 7", 1.0mm Straight Tips KATALYST SURGICAL LLC GEI 2026-10-07 00840096215359 Disposable Bipolar Forceps, 7", 1.5mm Straight Tips KATALYST SURGICAL LLC GEI 2026-10-07 00840096215366 Disposable Bipolar Forceps, 8", 0.5mm Straight Tips KATALYST SURGICAL LLC GEI 2026-10-07 00840096215373 Disposable Bipolar Forceps, 8", 1.0mm Straight Tips KATALYST SURGICAL LLC GEI 2026-10-07 00840096215397 Disposable Bipolar Forceps, 9", 0.5mm Straight Tips KATALYST SURGICAL LLC GEI 2026-10-07 00840096215403 Disposable Bipolar Forceps, 9", 1.0mm Straight Tips KATALYST SURGICAL LLC GEI 2026-10-07 00840096215410 Disposable Bipolar Forceps, 9", 1.5mm Straight Tips KATALYST SURGICAL LLC GEI 2026-10-07 00190776434328 Millennium Avalign Technologies, Inc. GEI 2026-10-06 B382SD134188100 Surgical Direct Surgical Direct, Inc. GEI 2026-10-06 B382SD13798330 Surgical Direct Surgical Direct, Inc. GEI 2026-10-06 00190776433284 Millennium Avalign Technologies, Inc. GEI 2026-10-05 00848657078467 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GEI 2026-10-05 00848657078474 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GEI 2026-10-05 00848657083782 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GEI 2026-10-05 00848657083812 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GEI 2026-10-05 00848657083843 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GEI 2026-10-05 00848657083874 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GEI 2026-10-05 00848657083898 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GEI 2026-10-05 00848657084956 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GEI 2026-10-05 00848657084963 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GEI 2026-10-05
megadyne.com