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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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Sapphire II Pro - 06934955942044

Balloon Dilatation Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
210-153-5UU
In Commercial Distribution

  • 06934955942044 ()

  • Length: 15 Millimeter
  • Outer Diameter: 1.0 Millimeter


  • Peripheral angioplasty balloon catheter, basic
  • Coronary angioplasty balloon catheter, basic

Sapphire II Pro - 06934955942037

Balloon Dilatation Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
210-103-5UU
In Commercial Distribution

  • 06934955942037 ()

  • Outer Diameter: 1.0 Millimeter
  • Length: 10 Millimeter


  • Peripheral angioplasty balloon catheter, basic
  • Coronary angioplasty balloon catheter, basic

Sapphire II Pro - 06934955942020

Balloon Dilatation Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
210-083-5UU
In Commercial Distribution

  • 06934955942020 ()

  • Length: 8 Millimeter
  • Outer Diameter: 1.0 Millimeter


  • Peripheral angioplasty balloon catheter, basic
  • Coronary angioplasty balloon catheter, basic

Sapphire II Pro - 06934955942013

Balloon Dilatation Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
210-053-5UU
In Commercial Distribution

  • 06934955942013 ()

  • Outer Diameter: 1.0 Millimeter
  • Length: 5 Millimeter


  • Peripheral angioplasty balloon catheter, basic
  • Coronary angioplasty balloon catheter, basic

FLASH Ostial System - M917OCB5019BA0

FLASH Ostial System, Dual Balloon Angioplasty Catheter, 5.0mm x 17mm
Verge Medical, Inc.
OCB5019BA
In Commercial Distribution

  • M917OCB5019BA0 ()

  • Catheter Length: 135cm
  • Distal Balloon Length: 17mm
  • Distal Balloon Diameter: 5.0mm
OCB5019BA

  • Peripheral angioplasty balloon catheter, basic
  • Coronary angioplasty balloon catheter, basic

FLASH Ostial System - M917OCB5014BA0

FLASH Ostial System, Dual Balloon Angioplasty Catheter, 5.0mm x 12mm
Verge Medical, Inc.
OCB5014BA
In Commercial Distribution

  • M917OCB5014BA0 ()

  • Distal Balloon Diameter: 5.0mm
  • Distal Balloon Length: 12mm
  • Catheter Length: 135cm
OCB5014BA

  • Coronary angioplasty balloon catheter, basic
  • Peripheral angioplasty balloon catheter, basic

FLASH Ostial System - M917OCB4514BA0

FLASH Ostial System, Dual Balloon Angioplasty Catheter, 4.5mm x 12mm
Verge Medical, Inc.
OCB4514BA
In Commercial Distribution

  • M917OCB4514BA0 ()

  • Distal Balloon Diameter: 4.5mm
  • Distal Balloon Length: 12mm
  • Catheter Length: 135cm
OCB4514BA

  • Coronary angioplasty balloon catheter, basic
  • Peripheral angioplasty balloon catheter, basic

FLASH Ostial System - M917OCB4014BA0

FLASH Ostial System, Dual Balloon Angioplasty Catheter, 4.0mm x 12mm
Verge Medical, Inc.
OCB4014BA
In Commercial Distribution

  • M917OCB4014BA0 ()

  • Catheter Length: 135cm
  • Distal Balloon Length: 12mm
  • Distal Balloon Diameter: 4.0mm
OCB4014BA

  • Peripheral angioplasty balloon catheter, basic
  • Coronary angioplasty balloon catheter, basic

STERILE .010 NITINOL WIRE - 00880304547292

No Description
Biomet Orthopedics, LLC
904020
In Commercial Distribution

  • 70880304547291 ()
  • 00880304547292 ()
904020

  • Wire holding/twisting pliers

NxStage PureFlow B Solution - M535RFP4560

No Description
NXSTAGE MEDICAL, INC.
RFP-456
In Commercial Distribution

  • M535RFP4565 ()
  • M535RFP4560 ()


  • Haemodialysis dialysate solution
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