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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DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-150SOLID145
In Commercial Distribution

  • 10852528005237 ()

  • Crown Type, Solid
  • Intro Sheath 5 Fr
  • Max OD 0.063 inches
  • High Speed 120 krpm
  • Medium Speed 90 krpm
  • Low Speed 60 krpm
  • Guidewire Size OD 0.014 inches
  • Shaft Length 145 cm
  • Nose Length 10 mm
  • Crown Diameter 1.50 mm
7-10011

  • Mechanical atherectomy system catheter, peripheral
VIPERWIRE, ADVANCED, .012" DIA .012" SPRING TIP, 200CM, 5 PACK
Cardiovascular Systems, Inc.
VPR-GW-200
In Commercial Distribution

  • 30852528005224 ()
  • 10852528005220 ()

  • Length: 200 Centimeter
  • Max Shaft Diameter 0.012 inches
  • Max Tip Diameter 0.014 inches
7-10004

  • Peripheral vascular guidewire, manual
DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.25MM, 60CM SHAFT
Cardiovascular Systems, Inc.
DBP-125SOLID60
In Commercial Distribution

  • 10852528005213 ()

  • Intro Sheath 4 Fr
  • Max OD 0.053 inches
  • High Speed 140 krpm
  • Medium Speed 90 krpm
  • low speed 60 krpm
  • guidewire size OD 0.012 inches
  • Shaft Length 60 cm
  • Nose Length 10 mm
  • Crown Diameter 1.25 mm
  • Crown Type, Solid
7-10002

  • Mechanical atherectomy system catheter, peripheral
DIAMONDBACK PERIPHERAL, MICRO CROWN, 1.25MM, 60CM SHAFT
Cardiovascular Systems, Inc.
DBP-125MICRO60
In Commercial Distribution

  • 10852528005206 ()

  • Intro Sheath 4 Fr
  • Max OD 0.053 inches
  • High Speed 140 krpm
  • Medium Speed 90 krpm
  • Low Speed 60 krpm
  • guidewire size OD 0.012 inches
  • Shaft Length 60 cm
  • Nose Length 7 mm
  • Crown Size 1.25 mm
  • Crown Type, Micro
7-10001

  • Mechanical atherectomy system catheter, peripheral
Blood Pressure monitor designed to be used seamlessly with our proprietary hub or mobile app.
Blackbox Remote Patient Monitoring LLC
BPM-201W
Not in Commercial Distribution

  • B963BPM201W1 ()
  • BB1BB963201W1 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=523872#
INTERVENTIONAL SPINE, INC
6008
In Commercial Distribution

  • 00811954012694 ()
6008

  • Bone trephine, reusable
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=290070#
BEST MEDICAL INTERNATIONAL, INC.
1192-15
In Commercial Distribution

  • 00841365114991 ()


  • General-purpose brachytherapy system applicator, remote-afterloading
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=290070#
BEST MEDICAL INTERNATIONAL, INC.
1192-20
In Commercial Distribution

  • 00841365116841 ()


  • General-purpose brachytherapy system applicator, remote-afterloading
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=290070#
BEST MEDICAL INTERNATIONAL, INC.
1192-4
In Commercial Distribution

  • 00841365116292 ()


  • General-purpose brachytherapy system applicator, remote-afterloading
Micro Injection Needle Style II 11ga x 9cm Luer Lockhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Ebner Medical, LLC
AA7771109
In Commercial Distribution

  • 00840217906166 ()

  • Length: 9 Centimeter
  • Outer Diameter: 3.048 Millimeter


  • Surgical/emergency suction cannula, non-illuminating, reusable
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