Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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AtriCure Switch Box
ATRICURE, INC.
ASB3
In Commercial Distribution

  • 30840143903018 ()
  • 10840143901584 ()
  • 00818354010596 ()
A000435

  • Electrosurgical cable adaptor
Glidepath Tape (3-Unit)
ATRICURE, INC.
GPT300
In Commercial Distribution

  • 30840143901625 ()
  • 10840143900020 ()
  • 50840143903074 ()
  • 00818354010718 ()
A000437

  • Cardiac ablation system applicator introducer/sizer
Glidepath Tape (GPT200) (3-Unit)
ATRICURE, INC.
GPT200
In Commercial Distribution

  • 30840143901618 ()
  • 10840143900013 ()
  • 50840143903050 ()
  • 00818354016352 ()
A000678

  • Cardiac ablation system applicator introducer/sizer
Glidepath Tape (GPT100) (1-Unit)
ATRICURE, INC.
GPT100
In Commercial Distribution

  • 30840143901595 ()
  • 10840143900006 ()
  • 50840143903036 ()
  • 00818354010435 ()
A000248

  • Cardiac ablation system applicator introducer/sizer
Glidepath Tape (1-Unit)
ATRICURE, INC.
GPT300
In Commercial Distribution

  • 00818354016291 ()
A000423

  • Cardiac ablation system applicator introducer/sizer
Coolrail Linear Pen, 30 mm linear electrode
ATRICURE, INC.
MCR1
In Commercial Distribution

  • 00818354016499 ()

  • Length: 30 Millimeter
A000475-4

  • Cardiac radio-frequency ablation system generator
Glidepath Tape (1-Unit)
ATRICURE, INC.
GPT200
In Commercial Distribution

  • 00818354016352 ()
A000672

  • Cardiac ablation system applicator introducer/sizer
Glidepath Tape (1-Unit)
ATRICURE, INC.
GPT100
In Commercial Distribution

  • 00818354016345 ()
A000248

  • Cardiac ablation system applicator introducer/sizer
Glidepath Tape (3-Unit)
ATRICURE, INC.
GPT200
In Commercial Distribution

  • 00818354011326 ()
A000678

  • Cardiac ablation system applicator introducer/sizer
Isolator Long Pen TT, 33 cm long pen
ATRICURE, INC.
MAX5
In Commercial Distribution

  • 00818354011135 ()

  • Length: 33 Centimeter
A000625

  • Cardiac radio-frequency ablation system generator
Coolrail Linear Pen, 30 mm linear electrode
ATRICURE, INC.
MCR1
In Commercial Distribution

  • 00818354010893 ()

  • Length: 30 Millimeter
A000475

  • Cardiac radio-frequency ablation system generator
Isolator Synergy Surgical Ablation System, Glidepath Tape, Left Curve
ATRICURE, INC.
EML2
In Commercial Distribution

  • 00818354010824 ()
A000467

  • Cardiac radio-frequency ablation system generator
Isolator Synergy Surgical Ablation System, Glidepath Tape, Right Curve
ATRICURE, INC.
EMR2
In Commercial Distribution

  • 00818354010756 ()
A000452

  • Cardiac radio-frequency ablation system generator
Glidepath Tape (3-Unit)
ATRICURE, INC.
GPT300
In Commercial Distribution

  • 00818354010718 ()
A000437

  • Cardiac ablation system applicator introducer/sizer
AtriCure Switch Box
ATRICURE, INC.
ASB3
In Commercial Distribution

  • 00818354010596 ()
A000435

  • Electrosurgical cable adaptor
Isolator Synergy™ Surgical Ablation System Open, Short Jaw, Left Curve
ATRICURE, INC.
OSL2
In Commercial Distribution

  • 00818354010558 ()
A000432

  • Cardiac radio-frequency ablation system generator
Isolator Synergy™ Surgical Ablation System Open, Long Jaw, Left Curve
ATRICURE, INC.
OLL2
In Commercial Distribution

  • 00818354010503 ()
A000362

  • Cardiac radio-frequency ablation system generator
Isolator Linear Pen, 20 mm linear electrode
ATRICURE, INC.
MLP1
In Commercial Distribution

  • 00818354010473 ()

  • Length: 20 Millimeter
A000318

  • Cardiac radio-frequency ablation system generator
Glidepath Tape (3-Unit)
ATRICURE, INC.
GPT100
In Commercial Distribution

  • 00818354010435 ()
A000294

  • Cardiac ablation system applicator introducer/sizer
Isolator Transpolar Pen
ATRICURE, INC.
MAX1
In Commercial Distribution

  • 00818354010343 ()
A000163

  • Cardiac radio-frequency ablation system generator
Footswitch ASU2/ASU3
ATRICURE, INC.
ASU
In Commercial Distribution

  • 00818354010312 ()
A000049

  • Cardiac radio-frequency ablation system generator
The RF Ablation System V-1000 is a microprocessor-based generator. This generator provides up to 140 W of RF energy to be used for coagulation & ablation of vessel, tissue and bone.
RF Medical Co.,Ltd.
V-1000
In Commercial Distribution

  • 08809295147030 ()

  • Height: 226 Millimeter
  • Depth: 391 Millimeter
  • Width: 322 Millimeter
  • Weight: 13 Kilogram


  • Percutaneous radio-frequency ablation system generator
TAC-S E-FLEX VULCAN
Smith & Nephew, Inc.
7209637
In Commercial Distribution

  • 03596010470683 ()
7209637

  • Radio-frequency ablation system probe, reusable
ABLATOR E-FLEX VULCAN INTEGRATED
Smith & Nephew, Inc.
7209666
In Commercial Distribution

  • 03596010470669 ()
7209666

  • Radio-frequency ablation system probe, reusable
The CROMA Electrosurgical Generator is a tabletop, non-network connected, mains powered Electrosurgical Unit (ESU). The CROMA Electrosurgical Generator is intended to provide Radiofrequency (RF) and microwave (MW) energy for cutting, coagulation, and ablation of soft tissue, when used in conjunction with compatible electrosurgical instruments and accessories. The Creo Medical Electrosurgical System is not intended for use in cardiac procedures.
CREO MEDICAL LIMITED
PRD-EMR-050
In Commercial Distribution

  • 05060359561213 ()
  • 05060359561206 ()
PRD-EMR-050

  • Microwave/electrosurgical system generator
A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.
CREO MEDICAL LIMITED
7-EMR-050 V6.001
In Commercial Distribution

  • 05060359560919 ()
  • 05060359560926 ()
  • 05060359560513 ()
7-EMR-050

  • Microwave/electrosurgical system generator
A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.
CREO MEDICAL LIMITED
7-EMR-050 V6.01
In Commercial Distribution

  • 05060359560513 ()
7-EMR-050

  • Microwave/electrosurgical system generator
A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.
CREO MEDICAL LIMITED
Croma Generator V4.0
In Commercial Distribution

7-EMR-050

  • Microwave/electrosurgical system generator
A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.
CREO MEDICAL LIMITED
Generator 7-EMR-050 with Footswitch 2-EMR-050
Not in Commercial Distribution

  • 05060359560124 ()


  • Microwave/electrosurgical system generator
A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.
CREO MEDICAL LIMITED
Generator 7-EMR-050
Not in Commercial Distribution

  • 05060359560087 ()


  • Microwave/electrosurgical system generator
The Acessa ProVu Console Dual Foot Pedal
Hologic, Inc.
MS-06-0171
In Commercial Distribution

  • 15420045515314 ()
MS-06-0171

  • Electromagnetic device tracking/ultrasound guided radio-frequency ablation system console/generator
The Acessa ProVu Console
Hologic, Inc.
7100
In Commercial Distribution

  • 15420045515307 ()
7100

  • Electromagnetic device tracking/ultrasound guided radio-frequency ablation system console/generator
No Description
Gynesonics, Inc.
SW-002
In Commercial Distribution

  • 10817929020340 ()
SW-002

  • Ultrasound-guided radio-frequency ablation system software
Generator Accessories
ST. JUDE MEDICAL, INC.
H700504
In Commercial Distribution

  • 05415067005045 ()
H700504

  • Electrical-only medical device connection cable, reusable
Footswitch
ST. JUDE MEDICAL, INC.
H700501
In Commercial Distribution

  • 05415067005014 ()

  • Length: 15 Meter
H700501

  • Foot-switch, electrical
Footswitch
ST. JUDE MEDICAL, INC.
H700500
In Commercial Distribution

  • 05415067005007 ()

  • Length: 10 Meter
H700500

  • Foot-switch, electrical
Footswitch
ST. JUDE MEDICAL, INC.
H700499
In Commercial Distribution

  • 05415067004994 ()

  • Length: 5 Meter
H700499

  • Foot-switch, electrical
Footswitch
ST. JUDE MEDICAL, INC.
H700498
In Commercial Distribution

  • 05415067004987 ()

  • Length: 2.5 Meter
H700498

  • Foot-switch, electrical
CATHETER 239F3 FREEZOR MAX3 MED BLUE 9F
MEDTRONIC, INC.
239F3
In Commercial Distribution

  • 00643169504905 ()

  • Catheter shaft size 9 Fr
  • Length: 90.0 Centimeter
  • Catheter tip length 8 mm
  • Catheter curve length 55 mm


  • Cardiac cryosurgical system catheter
CATHETER 239F5 FREEZOR MAX5 LG ORANGE9F
MEDTRONIC, INC.
239F5
In Commercial Distribution

  • 00643169504899 ()

  • Catheter shaft size 9 Fr
  • Catheter tip length 8 mm
  • Catheter curve length 66 mm
  • Length: 90.0 Centimeter


  • Cardiac cryosurgical system catheter
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