Home GUDID 00850003231600 CellFX
Primary DI 00850003231600
Brand CellFX
Company Pulse Biosciences, Inc.
Model FG5004-01
Catalog number CTT0152
Device description CellFX Treatment Tip – 1.5 x 1.5mm [2mm]
Published 2021-02-26
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
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 10850003231607 Package GS1 6 In Commercial Distribution 00850003231600 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10850003231607 10850003231607 00850003231600 00850003231600 850003231600 0850003231600
GMDN Terms# Term, Definition table Term Definition Electrosurgical system An assembly of devices intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation 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). The assembly includes a mains electricity-powered (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and electrodes to apply the energy to the surgical site. Tissue resistance to the electrical current creates the heat as the current travels through the body between electrodes; it is not intended for inert gas-enhanced electrosurgery.
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 080114073 Device count 1 Lot or batch true Expiration date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850003231594 CellFX FG5003-01 CTT0151 2021-03-08 00850003231624 CellFX FG5006-01, FG6009-01 CTT0251 2021-03-08 00850003231631 CellFX FG5007-01, FG6010-01 CTT0252 2021-02-26 00850003231655 CellFX FG5012-01, FG6015-01 CTT0501 2021-03-08 00850003231662 CellFX FG5013-01, FG6016-01 CTT0502 2021-02-26 00850003231389 CellFX FG2100-01 CFX10 2021-02-26 00850003231419 CellFX FG2250-01 CH03 2021-02-26 10850003231591 CellFX FG5003-01 CTT0151 2021-03-08 10850003231621 CellFX FG5006-01, FG6009-01 CTT0251 2021-03-08 10850003231652 CellFX FG5012-01, FG6015-01 CTT0501 2021-03-08 10850003231607 CellFX FG5004-01 CTT0152 2021-02-26 10850003231638 CellFX FG5007-01, FG6010-01 CTT0252 2021-02-26 10850003231669 CellFX FG5013-01, FG6016-01 CTT0502 2021-02-26
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