Home GUDID 30614559103528 Megadyne
Primary DI 30614559103528
Brand Megadyne
Company MEGADYNE MEDICAL PRODUCTS, INC.
Model 0037BN
Device description Electrosurgical Pencil Button Switch E-Z Clean Coated Modified Blade Electrode 10 ft (3 m) cord Bulk Non Sterile
Published 2016-12-08
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
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 30614559103528 Package GS1 50 In Commercial Distribution 10614559103524 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 30614559103528 30614559103528 10614559103524 10614559103524
GMDN Terms# Term, Definition table Term Definition Open-surgery electrosurgical handpiece/electrode, monopolar, single-use A rigid device consisting of combined electrosurgical handpiece and monopolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a single-use device intended to be used in a sterile condition.
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
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 true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00190776429140 Millennium Avalign Technologies, Inc. GEI 2026-09-04 00840113233281 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233304 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233328 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233342 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233366 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233380 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233403 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233427 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233441 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233465 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233489 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233502 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233526 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113237326 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113237340 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113237593 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113237623 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113237661 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113237692 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00190776428006 Millennium Avalign Technologies, Inc. GEI 2026-08-27 00190776428037 Millennium Avalign Technologies, Inc. GEI 2026-08-27 B4193533010 Maxtown Medical Modern Surgical Instruments LLC GEI 2026-08-27 ESUMARS980010 Sutter Sutter Medizintechnik GmbH GEI 2026-08-27 00190776427436 Millennium Avalign Technologies, Inc. GEI 2026-08-26 00190776427542 Millennium Avalign Technologies, Inc. GEI 2026-08-26 00190776427573 Millennium Avalign Technologies, Inc. GEI 2026-08-26 00190776427672 Millennium Avalign Technologies, Inc. GEI 2026-08-26 00190776427689 Millennium Avalign Technologies, Inc. GEI 2026-08-26 B108890POAMUS00 BTL-890U BTL INDUSTRIES LIMITED GEI 2026-08-26
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