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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Catheter Extension Cable IBI Generator 1642
IRVINE BIOMEDICAL, INC.
402578
In Commercial Distribution

  • 05414734300254 ()

  • Length: 2.5 Meter
402578

  • Electrical-only medical device connection cable, reprocessed
CATHETER 2AF234 ARCTIC FRONT ADV US 23MM
MEDTRONIC, INC.
2AF234
Not in Commercial Distribution

  • 00643169504837 ()

  • Length: 95.0 Centimeter
  • Balloon inflation size 23 mm
  • Catheter shaft size 10.5 Fr


  • Cardiac cryosurgical system catheter
CATHETER 2AF284 ARCTIC FRONT ADV US 28MM
MEDTRONIC, INC.
2AF284
Not in Commercial Distribution

  • 00643169504783 ()

  • Balloon inflation size 28 mm
  • Catheter shaft size 10.5 Fr
  • Length: 95.0 Centimeter


  • Cardiac cryosurgical system catheter
CONSOLE 106A3 GENV US PLEXUS ROHS
MEDTRONIC, INC.
106A3
Not in Commercial Distribution

  • 00643169946644 ()


  • Cardiac cryosurgical system
CATHETER 2AF284 ARCTIC FRONT ADV US 28MM
MEDTRONIC, INC.
2AF284
Not in Commercial Distribution

  • 00643169939318 ()

  • Length: 95.0 Centimeter
  • Catheter tip width 28 mm
  • Catheter shaft size 10.5 Fr


  • Cardiac cryosurgical system catheter
CATHETER 2AF234 ARCTIC FRONT ADV US 23MM
MEDTRONIC, INC.
2AF234
Not in Commercial Distribution

  • 00643169939271 ()

  • Catheter tip width 23 mm
  • Catheter shaft size 10.5 Fr
  • Length: 95.0 Centimeter


  • Cardiac cryosurgical system catheter
CATH AFAPRO28 AFA PRO 28 US
MEDTRONIC, INC.
AFAPRO28
Not in Commercial Distribution

  • 00643169889903 ()

  • Length: 95.0 Centimeter
  • Catheter shaft size 10.5 Fr
  • Catheter tip width 28 mm


  • Cardiac cryosurgical system catheter
CATH AFAPRO23 AFA PRO 23 US
MEDTRONIC, INC.
AFAPRO23
Not in Commercial Distribution

  • 00643169889880 ()

  • Length: 95.0 Centimeter
  • Catheter shaft size 10.5 Fr
  • Catheter tip width 23 mm


  • Cardiac cryosurgical system catheter
CONSOLE 106A3 GEN V ROHS PLX MKS
MEDTRONIC, INC.
106A3
Not in Commercial Distribution

  • 00643169983892 ()


  • Cardiac cryosurgical system
CATHETER 2AF284 ARCTIC FRONT ADV US 28MM
MEDTRONIC, INC.
2AF284
In Commercial Distribution

  • 00643169976382 ()

  • Catheter tip width 28 mm
  • Catheter shaft size 10.5 Fr
  • Length: 95.0 Centimeter


  • Cardiac cryosurgical system catheter
CATHETER 2AF234 ARCTIC FRONT ADV US 23MM
MEDTRONIC, INC.
2AF234
Not in Commercial Distribution

  • 00643169976368 ()

  • Catheter shaft size 10.5 Fr
  • Catheter tip width 23 mm
  • Length: 95.0 Centimeter


  • Cardiac cryosurgical system catheter
CATHETER 2AFAST28 AF ADVANCE ST 28MM US
MEDTRONIC, INC.
2AFAST28
Not in Commercial Distribution

  • 00643169577749 ()

  • Catheter shaft size 10.5 Fr
  • Catheter tip width 28 mm
  • Length: 95.0 Centimeter


  • Cardiac cryosurgical system catheter
CATHETER 2AFAST23 AF ADVANCE ST 23MM US
MEDTRONIC, INC.
2AFAST23
Not in Commercial Distribution

  • 00643169577732 ()

  • Catheter tip width 23 mm
  • Length: 95.0 Centimeter
  • Catheter shaft size 10.5 Fr


  • Cardiac cryosurgical system catheter
Balloon Fill Media
CARDIOFOCUS, INC.
18-1342
In Commercial Distribution

  • 00868976000130 ()

  • Total Volume: 95 Milliliter
18-1342

  • Vascular balloon catheter fill-media
Endoscope
CARDIOFOCUS, INC.
18-1447
In Commercial Distribution

  • 00868976000123 ()
18-1447

  • Flexible fibreoptic arterioscope, reusable
No Description
Stockert GmbH
20084
In Commercial Distribution

  • 04260166373257 ()
M004GEN100200840

  • Electrical-only medical device connection cable, reusable
No Description
Stockert GmbH
20081
In Commercial Distribution

  • 04260166373240 ()
M004GEN100200810

  • Electrical-only medical device connection cable, reusable
No Description
Stockert GmbH
19945
In Commercial Distribution

  • 04260166373165 ()
M004GEN100199450

  • Frame/rail/pole device holder
No Description
Stockert GmbH
19946
In Commercial Distribution

  • 04260166373134 ()
M004GEN100199460

  • Electrical-only medical device connection cable, reusable
CONSOLE 106A3 GENV US ROHS
Medtronic CryoCath LP
106A3
Not in Commercial Distribution

  • 00643169352476 ()


  • Cardiac cryosurgical system
CATHETER 2AF284 AFA US 28MM
MEDTRONIC, INC.
2AF284
Not in Commercial Distribution

  • 00643169345614 ()

  • Catheter shaft size 10.5 Fr
  • Length: 95.0 Centimeter
  • Balloon inflation size 28 mm


  • Cardiac cryosurgical system catheter
CATHETER 2AF234 AFA US 23MM
MEDTRONIC, INC.
2AF234
Not in Commercial Distribution

  • 00643169345591 ()

  • Length: 95.0 Centimeter
  • Catheter shaft size 10.5 Fr
  • Balloon inflation size 23 mm


  • Cardiac cryosurgical system catheter
Cryoablation Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
M004CRBS2160
In Commercial Distribution

  • 00191506016463 ()

  • 11.8F Catheter Shaft Size
M004CRBS2160

  • Cardiac cryosurgical system catheter
Inter-Connection Box
BOSTON SCIENTIFIC CORPORATION
M004CRBS4130
In Commercial Distribution

  • 00191506015701 ()
M004CRBS4130

  • Electrosurgical cable adaptor
Remote Control
BOSTON SCIENTIFIC CORPORATION
M004CRBS6500
In Commercial Distribution

  • 00191506007737 ()
M004CRBS6500

  • Cardiac cryosurgical system remote control
RFA High-Power Patient Return Electrode Extension Cable
Covidien LP
DGP-HP-EXT
Not in Commercial Distribution

  • 10884524002088 ()


  • Electrical-only medical device connection cable, reusable
RFA High-Power Patient Return Electrode
Covidien LP
DGP-HP
In Commercial Distribution

  • 20884524001293 ()
  • 10884524001296 ()


  • Electrosurgical return electrode, single-use
RFA Single Electrode Kit
Covidien LP
ACT2530
In Commercial Distribution

  • 20884524001231 ()
  • 10884524001234 ()

  • tip exposure,3,Centimeter;
  • Length: 25 Centimeter


  • Rigid endoscopic scissors, reusable
RFA Single Electrode Kit
Covidien LP
ACT2030
In Commercial Distribution

  • 20884524001224 ()
  • 10884524001227 ()

  • Length: 20 Centimeter
  • tip exposure,3,Centimeter;


  • Rigid endoscopic scissors, reusable
RFA Single Electrode Kit
Covidien LP
ACT2020
In Commercial Distribution

  • 20884524001217 ()
  • 10884524001210 ()

  • tip exposure,2,Centimeter;
  • Length: 20 Centimeter


  • Rigid endoscopic scissors, reusable
RFA Cluster Electrode Kit
Covidien LP
ACTC1525
In Commercial Distribution

  • 20884524001200 ()
  • 10884524001203 ()

  • Length: 15 Centimeter
  • tip exposure,2.5,Centimeter;


  • Rigid endoscopic scissors, reusable
RFA Cluster Electrode Kit
Covidien LP
ACTC2025
In Commercial Distribution

  • 20884524001194 ()
  • 10884524001197 ()

  • tip exposure,2.5,Centimeter;
  • Length: 20 Centimeter


  • Rigid endoscopic scissors, reusable
RFA Single Electrode Kit
Covidien LP
ACT1520
In Commercial Distribution

  • 20884524001187 ()
  • 10884524001180 ()

  • Length: 15 Centimeter
  • tip exposure,2,Centimeter;


  • Rigid endoscopic scissors, reusable
RFA Single Electrode Kit
Covidien LP
ACT1510
In Commercial Distribution

  • 20884524001170 ()
  • 10884524001173 ()

  • Length: 15 Centimeter
  • tip exposure,1,Centimeter;


  • Rigid endoscopic scissors, reusable
RFA Single Electrode Kit
Covidien LP
ACT1507
In Commercial Distribution

  • 20884524001163 ()
  • 10884524001166 ()

  • Length: 14.4 Centimeter
  • tip exposure,0.7,Centimeter;


  • Rigid endoscopic scissors, reusable
RFA Single Electrode Kit
Covidien LP
ACT1530
In Commercial Distribution

  • 20884524000944 ()
  • 10884524000947 ()

  • tip exposure,3,Centimeter;
  • Length: 15 Centimeter


  • Rigid endoscopic scissors, reusable
RFA Cluster Electrode Kit
Covidien LP
ACTC1025
In Commercial Distribution

  • 40884524000931 ()
  • 10884524000930 ()

  • Length: 10 Centimeter
  • tip exposure,2.5,Centimeter;


  • Rigid endoscopic scissors, reusable
GOWN, ISOLATION LEVEL 1, BLUE, UNIVERSAL SIZE, HOOK & LOOP NECK, FULL BACK W/TIE AT WAIST, ELASTIC SLEEVE, 5EA/PK, 20PK/CS (100EA/CS)
Asp Global, LLC
HH-2020-060-1
In Commercial Distribution

  • 00840216123014 ()


  • Isolation gown, single-use
DOCK, VISITAG SURPOINT EPU SP
Biosense Webster Inc
M665701SP
In Commercial Distribution

  • 10846835018585 ()
M665701SP

  • Cardiac mapping system computer
EXT PROCESSING UNIT ACCESSORIE
Biosense Webster Inc
M660201SP
In Commercial Distribution

  • 10846835018578 ()
M660201SP

  • Cardiac mapping system computer
EXT PROCESSING UNIT ACCESSORIE
Biosense Webster Inc
M660202SP
In Commercial Distribution

  • 10846835018554 ()
M660202SP

  • Cardiac mapping system computer
External Processing Unit
Biosense Webster Inc
D160801
In Commercial Distribution

  • 10846835017885 ()
D160801

  • Cardiac mapping system computer
Laparoscopic Ultrasound Tracking Sensor. For use with BK Medical Type 8666-RF laparoscopic ultrasound probes
Covidien LP
CABK8666L
In Commercial Distribution

  • 10884521703346 ()


  • Non-evacuated blood collection tube IVD, clot activator/separator
Open Ultrasound Tracking Sensor. For use with BK Medical. Type 8816 open ultrasound probes
Covidien LP
CABK8816
In Commercial Distribution

  • 10884521703339 ()


  • Non-evacuated blood collection tube IVD, clot activator/separator
Laparoscopic Ultrasound Tracking Sensor. For use with Hitachi Aloka UST-9150 laparoscopic ultrasound probes
Covidien LP
CAAL9150L
In Commercial Distribution

  • 10884521703322 ()


  • Non-evacuated blood collection tube IVD, clot activator/separator
Open Ultrasound Tracking Sensor. For use with Hitachi Aloka UST-9132T open ultrasound probes
Covidien LP
CAAL9132
In Commercial Distribution

  • 10884521703315 ()


  • Non-evacuated blood collection tube IVD, clot activator/separator
Field Generator Spacer
Covidien LP
CAFGSP1
In Commercial Distribution

  • 10884521703261 ()


  • Foam-filled bed mattress overlay
Field Generator Cart
Covidien LP
CAFGCART1
In Commercial Distribution

  • 10884521703230 ()


  • Electromechanical device/system transport trolley
Field Generator
Covidien LP
CAFG1
In Commercial Distribution

  • 10884521703223 ()


  • Non-evacuated blood collection tube IVD, clot activator/separator
Cryo-Console Foot Switch
BOSTON SCIENTIFIC CORPORATION
M004CRBS4200
In Commercial Distribution

  • 08714729992745 ()
M004CRBS4200

  • Foot-switch, electrical
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