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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 - 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

Voca - 00781096541676

Spectacle Frame, Size 65-21-127
MCGEE GROUP, INC., THE
VC Kong Slate Black/Smoke Red
In Commercial Distribution

  • 00781096541676 ()
VCKONGSBSROOSND

  • Spectacle frame

Key Surgical General Instruments - 00849771011903

German Stainless Steel Pliers, Needle Nose Locking Pliers, 12-inch large
KEY SURGICAL, INC.
KI-48-610
Not in Commercial Distribution

  • 00849771011903 ()
KI48610

  • Wire holding/twisting pliers

Key Surgical General Instruments - 00849771011873

German Stainless Steel Pliers, Needle Nose Locking Pliers, Medium, 9.5-inch long
KEY SURGICAL, INC.
KI-48-606
Not in Commercial Distribution

  • 00849771011873 ()


  • Wire holding/twisting pliers

Key Surgical General Instruments - 00849771011866

German Stainless Steel Pliers, Parallel Pliers, 7.25-inch, with cutter, .062-inch max
KEY SURGICAL, INC.
KI-48-605
Not in Commercial Distribution

  • 00849771011866 ()
KI-48-605

  • Wire holding/twisting pliers

Key Surgical General Instruments - 00849771011859

German Stainless Steel Pliers, Parallel Pliers, 7.25-inch
KEY SURGICAL, INC.
KI-48-604
Not in Commercial Distribution

  • 00849771011859 ()


  • Wire holding/twisting pliers
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