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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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Ultra-soft™ SV - 08714729390800

Balloon Dilatation Catheter
BOSTON SCIENTIFIC CORPORATION
H7493791670200
Not in Commercial Distribution

  • 08714729390800 ()

  • 153 cm Effective Length
  • 7.0 mm Diameter
  • 20 mm Length


  • Peripheral angioplasty balloon catheter, basic

Ultra-soft™ SV - 08714729390770

Balloon Dilatation Catheter
BOSTON SCIENTIFIC CORPORATION
H7493791665150
Not in Commercial Distribution

  • 08714729390770 ()

  • 6.5 mm Diameter
  • 15 mm Length
  • 153 cm Effective Length


  • Peripheral angioplasty balloon catheter, basic

Ultra-soft™ SV - 08714729390671

Balloon Dilatation Catheter
BOSTON SCIENTIFIC CORPORATION
H7493791640150
Not in Commercial Distribution

  • 08714729390671 ()

  • 4.0 mm Diameter
  • 153 cm Effective Length
  • 15 mm Length


  • Peripheral angioplasty balloon catheter, basic

Ultra-soft™ SV - 08714729390657

Balloon Dilatation Catheter
BOSTON SCIENTIFIC CORPORATION
H7493791570150
Not in Commercial Distribution

  • 08714729390657 ()

  • 15 mm Length
  • 7.0 mm Diameter
  • 93 cm Effective Length


  • Peripheral angioplasty balloon catheter, basic

Ultra-soft™ SV - 08714729390633

Balloon Dilatation Catheter
BOSTON SCIENTIFIC CORPORATION
H7493791565150
Not in Commercial Distribution

  • 08714729390633 ()

  • 93 cm Effective Length
  • 15 mm Length
  • 6.5 mm Diameter


  • Peripheral angioplasty balloon catheter, basic

EDD - External Drainage and Depression Device - B384VS0290

External Drainage and Depression
Vortex Surgical, Inc.
Straight
In Commercial Distribution

  • B384VS0290 ()
VS0290

  • Vitrectomy fluid/gas handling handpiece/cannula

Versatile Soft Tip - B384VS0280251

Extendable Soft Tip
Vortex Surgical, Inc.
25ga
In Commercial Distribution

  • B384VS0280251 ()
VS0280.25

  • Vitrectomy fluid/gas handling handpiece/cannula

Versatile Soft Tip - B384VS0280231

Extendable Soft Tip
Vortex Surgical, Inc.
23ga
In Commercial Distribution

  • B384VS0280231 ()
VS0280.23

  • Vitrectomy fluid/gas handling handpiece/cannula

Subretinal Injection Cannula - B384VS0220251

Subretinal Injection Cannula for use with TPA
Vortex Surgical, Inc.
25ga
In Commercial Distribution

  • B384VS0220251 ()
VS0220.25

  • Vitrectomy fluid/gas handling handpiece/cannula

Atraumatic Soft Tip - B384VS0210251

25ga Atraumatic Soft Tip
Vortex Surgical, Inc.
25ga
In Commercial Distribution

  • B384VS0210251 ()
VS0210.25

  • Vitrectomy fluid/gas handling handpiece/cannula

Atraumatic Soft Tip - B384VS0210231

23ga Atraumatic Soft Tip
Vortex Surgical, Inc.
23ga
In Commercial Distribution

  • B384VS0210231 ()
VS0210.23

  • Vitrectomy fluid/gas handling handpiece/cannula

27ga Soft Tip Cannula - B384VS02002719

27ga Soft Tip Cannula
Vortex Surgical, Inc.
VS0200.27
In Commercial Distribution

  • B384VS0200275 ()
  • B384VS02002719 ()
VS0200.27

  • Vitrectomy fluid/gas handling handpiece/cannula

25ga Soft Tip Cannula - B384VS0200251

25ga Soft Tip Cannula
Vortex Surgical, Inc.
VS0200.25
In Commercial Distribution

  • B384VS0200255 ()
  • B384VS0200251 ()

  • Needle Gauge: 25 Gauge
VS0200.25

  • Vitrectomy fluid/gas handling handpiece/cannula

23ga Soft Tip Cannula - B384VS0200231

23ga Soft Tip Cannula
Vortex Surgical, Inc.
VS0200.23
In Commercial Distribution

  • B384VS0200235 ()
  • B384VS0200231 ()

  • Needle Gauge: 23 Gauge
VS0200.23

  • Vitrectomy fluid/gas handling handpiece/cannula

25ga Soft Tip Cannula - Bulk - B3842002517

Bulk (100) 25ga Soft Tip Cannula
Vortex Surgical, Inc.
25ga Soft Tip Cannula
In Commercial Distribution

  • B3842002517 ()
VS0200.25B

  • Vitrectomy fluid/gas handling handpiece/cannula

PolarCath - B479T6040135010

Peripheral dilation catheter, over the wire 6F (6.0mm x 40mm, 135cm)
Nucryo Vascular
T604013501
In Commercial Distribution

  • B479T6040135010 ()


  • Peripheral angioplasty balloon catheter, basic

PolarCath - B479T60150135010

PolarCath peripheral dilation catheter over the wire 7F . ( 6.0mm x 150mm, 135cm)
Nucryo Vascular
T6015013501
In Commercial Distribution

  • B479T60150135010 ()


  • Peripheral angioplasty balloon catheter, basic

PolarCath - B479T60100135010

PolarCath peripheral dilation catheter over the wire 6F . ( 6.0mm x 100mm, 135cm)
Nucryo Vascular
T6010013501
In Commercial Distribution

  • B479T60100135010 ()


  • Peripheral angioplasty balloon catheter, basic

PolarCath - B479T5040135010

PolarCath peripheral dilation catheter over the wire 5.5F . ( 5.0mm x 40mm, 135cm)
Nucryo Vascular
T504013501
In Commercial Distribution

  • B479T5040135010 ()


  • Peripheral angioplasty balloon catheter, basic

PolarCath - B479T50150135010

Peripheral dilation catheter, over the wire 6F (5.0mm x 150mm, 135cm)
Nucryo Vascular
T5015013501
In Commercial Distribution

  • B479T50150135010 ()


  • Peripheral angioplasty balloon catheter, basic

PolarCath - B479T50100135010

Peripheral dilation catheter, over the wire 6F (5.0mm x 100mm, 135cm)
Nucryo Vascular
T5010013501
In Commercial Distribution

  • B479T50100135010 ()


  • Peripheral angioplasty balloon catheter, basic

PolarCath - B479T4040150010

PolarCath peripheral dilation catheter over the wire 5F . ( 4.0mm x 40mm, 150cm)
Nucryo Vascular
T404015001
In Commercial Distribution

  • B479T4040150010 ()


  • Peripheral angioplasty balloon catheter, basic

PolarCath - B479T40150150010

PolarCath peripheral dilation catheter over the wire 5F . ( 4.0mm x 150mm, 150cm)
Nucryo Vascular
T4015015001
In Commercial Distribution

  • B479T40150150010 ()


  • Peripheral angioplasty balloon catheter, basic

PolarCath - B479T40100150010

PolarCath peripheral dilation catheter over the wire 5F . ( 4.0mm x 100mm, 150cm)
Nucryo Vascular
T4010015001
In Commercial Distribution

  • B479T40100150010 ()


  • Peripheral angioplasty balloon catheter, basic

PolarCath - B479T3540150010

PolarCath peripheral dilation catheter over the wire 5F . ( 3.5mm x 40mm, 150cm)
Nucryo Vascular
T354015001
In Commercial Distribution

  • B479T3540150010 ()


  • Peripheral angioplasty balloon catheter, basic

PolarCath - B479T35150150010

PolarCath peripheral dilation catheter over the wire 5F . (3.5mm x 150mm, 150cm)
Nucryo Vascular
T3515015001
In Commercial Distribution

  • B479T35150150010 ()


  • Peripheral angioplasty balloon catheter, basic

PolarCath - B479T35100150010

PolarCath peripheral dilation catheter over the wire 5F . ( 3.5mm x 100mm, 150cm)
Nucryo Vascular
T3510015001
In Commercial Distribution

  • B479T35100150010 ()


  • Peripheral angioplasty balloon catheter, basic

PolarCath - B479T3040150010

PolarCath peripheral dilation catheter over the wire 5F . ( 3.0mm x 40mm, 150cm)
Nucryo Vascular
T304015001
In Commercial Distribution

  • B479T3040150010 ()


  • Peripheral angioplasty balloon catheter, basic

PolarCath - B479T30150150010

PolarCath peripheral dilation catheter over the wire 5F . ( 3.0mm x 150mm, 150cm)
Nucryo Vascular
T3015015001
In Commercial Distribution

  • B479T30150150010 ()


  • Peripheral angioplasty balloon catheter, basic

PolarCath - B479T30100150010

PolarCath peripheral dilation catheter over the wire 5F . ( 3.0mm x 100mm, 150cm)
Nucryo Vascular
T3010015001
In Commercial Distribution

  • B479T30100150010 ()


  • Peripheral angioplasty balloon catheter, basic

PolarCath - B479T2540150010

PolarCath peripheral dilation catheter over the wire 5F . ( 2.5mm x 40mm, 150cm)
Nucryo Vascular
T254015001
In Commercial Distribution

  • B479T2540150010 ()


  • Peripheral angioplasty balloon catheter, basic

PolarCath - B479T25150150010

PolarCath peripheral dilation catheter over the wire 5F . ( 2.5mm x 150mm, 150cm)
Nucryo Vascular
T2515015001
In Commercial Distribution

  • B479T25150150010 ()


  • Peripheral angioplasty balloon catheter, basic

PolarCath - B479T25100150010

PolarCath peripheral dilation catheter over the wire 5F . ( 2.5mm x 100mm, 150cm)
Nucryo Vascular
T2510015001
In Commercial Distribution

  • B479T25100150010 ()


  • Peripheral angioplasty balloon catheter, basic

PolarCath - B479T2040150010

Peripheral dilation catheter, over the wire 5F (2.0mm x 40mm, 150cm)
Nucryo Vascular
T204015001
In Commercial Distribution

  • B479T2040150010 ()


  • Peripheral angioplasty balloon catheter, basic

PolarCath - B479T20150150010

PolarCath peripheral dilation catheter over the wire 5F . ( 2.0mm x 150mm, 150cm)
Nucryo Vascular
T2015015001
In Commercial Distribution

  • B479T20150150010 ()


  • Peripheral angioplasty balloon catheter, basic

PolarCath - B479T20100150010

PolarCath peripheral dilation catheter over the wire 5F . ( 2.0mm x 100mm, 150cm)
Nucryo Vascular
T2010015001
In Commercial Distribution

  • B479T20100150010 ()


  • Peripheral angioplasty balloon catheter, basic

CryoPlasty - B479PCIU5000000

CryoPlasty inflation unit for use with PolarCath peripheral dilation system
Nucryo Vascular
PCIU500000
In Commercial Distribution

  • B479PCIU5000000 ()


  • Peripheral angioplasty balloon catheter, basic

PolarCath - B479PCE10000000

PolarCath catheter extension for use with PolarCath peripheral dilation system
Nucryo Vascular
PCE1000000
In Commercial Distribution

  • B479PCE10000000 ()
  • B479PCE10000001 ()


  • Peripheral angioplasty balloon catheter, basic

PolarCath - B479P840120010

PolarCath peripheral dilation catheter over the wire 8F. ( 8.0mm x 40mm, 120cm)
Nucryo Vascular
P84012001
In Commercial Distribution

  • B479P840120010 ()


  • Peripheral angioplasty balloon catheter, basic

PolarCath - B479P740120010

PolarCath peripheral dilation catheter over the wire 7F . (7.0mm x 40mm, 120cm)
Nucryo Vascular
P74012001
In Commercial Distribution

  • B479P740120010 ()


  • Peripheral angioplasty balloon catheter, basic
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