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 EPT Generator 1779-SE
IRVINE BIOMEDICAL, INC.
402577
In Commercial Distribution

  • 05414734300247 ()

  • Length: 2.5 Meter
402577

  • Electrical-only medical device connection cable, reprocessed
KIT 20MRK ARCTIC FRNT MANETRACT GLB ROHS
MEDTRONIC, INC.
20MRK
In Commercial Distribution

  • 00643169495814 ()


  • Catheter/overtube balloon inflator, single-use
CONSOLE 106A3 GEN V CRYOCONSOLE
Medtronic CryoCath LP
106A3
In Commercial Distribution

  • 00643169449596 ()


  • Cardiac cryosurgical system
TactiFlex Radiofrequency Cable
ST. JUDE MEDICAL, INC.
TSQ-RF-TFSE-CBL
In Commercial Distribution

  • 05415067034700 ()

  • Length: 2.0000 Meter
TSQ-RF-TFSE-CBL

  • Electrical-only medical device connection cable, reusable
Bedrail Clamp (North America)
ST. JUDE MEDICAL, INC.
Bedrail Clamp
In Commercial Distribution

  • 05415067029362 ()
BED-CLP-NA

  • Medical device service rail clamp
Tactisys to Precision Above Mounting Bracket
ST. JUDE MEDICAL, INC.
TSM-ABV-GBL
In Commercial Distribution

  • 05415067029355 ()
TSM-ABV-GBL

  • Medical device service rail clamp
Tactisys to Precision Beside Mounting Bracket
ST. JUDE MEDICAL, INC.
TSM-BSD-GBL
In Commercial Distribution

  • 05415067029348 ()
TSM-BSD-GBL

  • Medical device service rail clamp
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
CONSOLE 106A3 GEN V CRYOCONSOLE US CAN
MEDTRONIC, INC.
106A3
Not in Commercial Distribution

  • 00613994775955 ()


  • Cardiac cryosurgical system
CONSOLE 106A3 GEN V CRYOCONSOLE US
MEDTRONIC, INC.
106A3
Not in Commercial Distribution

  • 00613994686077 ()


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

  • 00643169753693 ()

  • Balloon inflation size 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
In Commercial Distribution

  • 00643169753686 ()

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


  • Cardiac cryosurgical system catheter
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
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 2AF282 ARCTIC FRONT 28MM BLUE
MEDTRONIC, INC.
2AF282
Not in Commercial Distribution

  • 00643169073265 ()

  • Balloon inflation size 28 mm
  • Balloon tip size 9 Fr
  • Catheter shaft size 10.5 Fr
  • Length: 100.0 Centimeter


  • Cardiac cryosurgical system catheter
CATHETER 2AF232 ARCTIC FRONT 23MM RED
MEDTRONIC, INC.
2AF232
Not in Commercial Distribution

  • 00643169073258 ()

  • Length: 100.0 Centimeter
  • Catheter shaft size 10.5 Fr
  • Balloon tip size 9 Fr
  • Balloon inflation size 23 mm


  • Cardiac cryosurgical system catheter
KIT 20MRK ARCTIC FRONT MANUALRETRACTION
MEDTRONIC, INC.
20MRK
Not in Commercial Distribution

  • 00643169023239 ()


  • Catheter/overtube balloon inflator, single-use
CATHETER 2AF234 ARCTIC FRONT ADV US 23MM
MEDTRONIC, INC.
2AF234
Not in Commercial Distribution

  • 00643169105515 ()

  • Balloon inflation size 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
20402
In Commercial Distribution

  • 04260166374087 ()
M004GEN100204020

  • Bedside infusion pump, single-channel
No Description
Stockert GmbH
20087
In Commercial Distribution

  • 04260166373264 ()
M004GEN100200870

  • Electrical-only medical device connection cable, 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
No Description
Biosense Webster Inc
C6MR10EPTRS
In Commercial Distribution

  • 10846835003666 ()
C6MR10EPTRS

  • Electrical-only medical device connection cable, reusable
No Description
Biosense Webster Inc
C10MRMSTKDTCS
In Commercial Distribution

  • 10846835003406 ()
C10MRMSTKDTCS

  • Electrical-only medical device connection cable, reusable
No Description
Biosense Webster Inc
C5MHDTCMHS
In Commercial Distribution

  • 10846835000191 ()
C5MHDTCMHS

  • Electrical-only medical device connection cable, reusable
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
No Description
Biosense Webster Inc
C6MR10EPTST
In Commercial Distribution

  • 10846835003680 ()
C6MR10EPTST

  • Electrical-only medical device connection cable, reusable
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