Home GUDID 10850003231607 CellFX
Primary DI 10850003231607
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 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 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 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 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 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# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00197998302718 Solventum™ Solventum US LLC GEI 2026-09-25 00724995269586 Snowden-Pencer STERIS Deutschland GmbH GEI 2026-09-25 00724995269951 Snowden-Pencer STERIS Deutschland GmbH GEI 2026-09-25 00724995269968 Snowden-Pencer STERIS Deutschland GmbH GEI 2026-09-25 00190776432300 Millennium Avalign Technologies, Inc. GEI 2026-09-24 00190776432317 Millennium Avalign Technologies, Inc. GEI 2026-09-24 00190776432324 Millennium Avalign Technologies, Inc. GEI 2026-09-24 00190776432430 Millennium Avalign Technologies, Inc. GEI 2026-09-24 00190776432447 Millennium Avalign Technologies, Inc. GEI 2026-09-24 00190776432454 Millennium Avalign Technologies, Inc. GEI 2026-09-24 00190776431457 Millennium Avalign Technologies, Inc. GEI 2026-09-22 00190776432041 Millennium Avalign Technologies, Inc. GEI 2026-09-22 00190776432195 Millennium Avalign Technologies, Inc. GEI 2026-09-22 00190776432201 Millennium Avalign Technologies, Inc. GEI 2026-09-22 00190776431181 Millennium Avalign Technologies, Inc. GEI 2026-09-21 00190776431198 Millennium Avalign Technologies, Inc. GEI 2026-09-21 00190776431204 Millennium Avalign Technologies, Inc. GEI 2026-09-21 00190776431211 Millennium Avalign Technologies, Inc. GEI 2026-09-21 00190776431228 Millennium Avalign Technologies, Inc. GEI 2026-09-21 00190776431235 Millennium Avalign Technologies, Inc. GEI 2026-09-21 00190776431242 Millennium Avalign Technologies, Inc. GEI 2026-09-21 00190776431259 Millennium Avalign Technologies, Inc. GEI 2026-09-21 10840113236852 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-21 10840113236890 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-21 10840113236937 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-21 10840113237040 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-21 10840113237064 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-21 10840113237101 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-21 10840113237118 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-21 10840113237132 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-21