Home GUDID 10850003231591 CellFX
Primary DI 10850003231591
Brand CellFX
Company Pulse Biosciences, Inc.
Model FG5003-01
Catalog number CTT0151
Device description CellFX Treatment Tip – 1.5 x 1.5mm [1mm]
Published 2021-03-08
Public version status New
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 10850003231591 Package GS1 6 In Commercial Distribution 00850003231594 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 10850003231591 10850003231591 00850003231594 00850003231594 850003231594 0850003231594
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 argon-enhanced electrosurgery.
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 080114073 Device count 1 DM exempt false 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850003231594 CellFX FG5003-01 CTT0151 2021-03-08 00850003231600 CellFX FG5004-01 CTT0152 2021-02-26 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 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
Other Devices Sharing Product Codes#