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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 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
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
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
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
Display Workstation
ST. JUDE MEDICAL, INC.
PN-004711
In Commercial Distribution

  • 07640157990316 ()
PN-004711

  • Cardiac mapping system computer
Analog Output Cable
ST. JUDE MEDICAL, INC.
PN-001427
In Commercial Distribution

  • 07640157990217 ()
PN-001427

  • Electrical-only medical device connection cable, reusable
Quartz Equipment
ST. JUDE MEDICAL, INC.
PN-004400
In Commercial Distribution

  • 07640157990194 ()
PN-004400

  • Cardiac mapping system computer
Mount
ST. JUDE MEDICAL, INC.
PN-004511
In Commercial Distribution

  • 07640157990187 ()
PN-004511

  • Medical device service rail clamp
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