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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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IMPROSAFE® Multi Sample Needle - 06933395620802

No Description
Guangzhou Improve Medical Instruments Co., Ltd.
21G x 1”
In Commercial Distribution

  • 56933395620807 ()
  • 16933395620809 ()
  • 06933395620802 ()
  • 46933395620800 ()
  • 26933395620806 ()
  • 66933395620804 ()


  • Non-fixed blood collection needle

MAGELLAN - 09120052070996

Reader control and data reduction software for Tecan Microplate Reader.
Tecan Austria GmbH
MAGELLAN V7.X
In Commercial Distribution

  • 09120052070996 ()
30183889

  • Laboratory instrument/analyser application software IVD

Vaku-8 - 08903347023478

VAKU-8 Blood Collection Set, 25G X ¾" (0.50X19MM) 12" TUBE MYCO REORDER # SVMS-25A
HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED
25 G X ¾"
In Commercial Distribution

  • 18903347023475 ()
  • 08903347023478 ()
  • 28903347023472 ()
  • 58903347023473 ()
02347

  • Venous butterfly needle/set

Vaku-8 - 08903347023461

VAKU-8 Blood Collection Set,23G X ¾" ( 0.60 X 19MM ) 12" TUBE MYCO RE-ORDER # SVMS-23A
HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED
23 G X ¾"
In Commercial Distribution

  • 18903347023468 ()
  • 08903347023461 ()
  • 28903347023465 ()
  • 58903347023466 ()
02346

  • Venous butterfly needle/set

Vaku-8 - 08903347023454

VAKU-8 Blood Collection Set,21 G X ¾" (0.80X19MM ) 12" TUBE MYCO RE-ORDER # SVMS-21A
HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED
21 G X ¾"
In Commercial Distribution

  • 08903347023454 ()
  • 18903347023451 ()
  • 28903347023458 ()
  • 58903347023459 ()
02345

  • Venous butterfly needle/set

VAKU-8+ - 08903347023423

VAKU-8 + Blood Collection Set,21 G X ¾" ( 0.80X19MM) 7" TUBE MYCO RE-ORDER # SVMSP-21L
HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED
21 G X ¾"
In Commercial Distribution

  • 08903347023423 ()
  • 18903347023420 ()
  • 28903347023427 ()
  • 58903347023428 ()
02342

  • Venous butterfly needle/set

Unolok - 08903347003302

UNOLOK Luer Lock Infusion Sets,25 G X ¾" ( 0.50X19MM) 12" TUBE MYCO RE-ORDER # 7001-25
HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED
25 G X ¾"
In Commercial Distribution

  • 08903347003302 ()
  • 18903347003309 ()
  • 28903347003306 ()
  • 58903347003307 ()
00330

  • Venous butterfly needle/set

Unolok - 08903347003289

UNOLOK Luer Lock Infusion Sets,23 G X ¾" (0.60 X19MM ) 12" TUBE MYCO RE-ORDER # 7001-23
HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED
23 G X ¾"
In Commercial Distribution

  • 08903347003289 ()
  • 18903347003286 ()
  • 28903347003283 ()
  • 58903347003284 ()
00328

  • Venous butterfly needle/set

UNOLOK - 08903347003265

UNOLOK Luer Lock Infusion Set,21 G X ¾" ( 0.80X19MM) 12" TUBE MYCO RE-ORDER # 7001-21
HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED
21 G X ¾"
In Commercial Distribution

  • 08903347003265 ()
  • 18903347003262 ()
  • 28903347003269 ()
  • 58903347003260 ()
00326

  • Venous butterfly needle/set

UNOLOK - 08903347003241

UNOLOK Luer Lock Infusion Set,19 G X ¾" ( 1.10X19MM) 12" TUBE MYCO RE-ORDER # 7001-19
HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED
19 G X ¾"
In Commercial Distribution

  • 08903347003241 ()
  • 18903347003248 ()
  • 28903347003245 ()
  • 58903347003246 ()
00324

  • Venous butterfly needle/set

UNOLOK+ - 08903347002343

UNOLOK+ Luer Lock Infusion Set,21 G X ¾" ( 0.80X19MM) 7" TUBE MYCO RE-ORDER # 7001P-21L
HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED
21 G X ¾"
In Commercial Distribution

  • 08903347002343 ()
  • 18903347002340 ()
  • 28903347002347 ()
  • 58903347002348 ()
00234

  • Venous butterfly needle/set

UNOLOK+ - 08903347002336

UNOLOK+ Luer Lock Infusion Set,19 G X ¾" ( 1.10X19MM) 7" TUBE MYCO RE-ORDER # 7001P-19L
HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED
19 G X ¾"
In Commercial Distribution

  • 08903347002336 ()
  • 18903347002333 ()
  • 28903347002330 ()
  • 58903347002331 ()
00233

  • Venous butterfly needle/set

Shockwave M5 - 00195451000195

The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Shockwave Medical, Inc.
7.0 x 60mm
In Commercial Distribution


  • Catheter Working Length: 110 Centimeter
  • Balloon Diameter: 7.0 Millimeter
  • Balloon Nominal (Inflation) Pressure: 6 Atmosphere
  • Balloon Rated Burst Pressure: 10 Atmosphere
  • Balloon Length: 60 Millimeter
  • Introducer Sheath Compatibility: 7 French
  • Balloon Proximal Outer Diameter (OD): 0.072 Inch
  • Guidewire Diameter: 0.014 Inch
M5IVL7060

  • Intravascular lithotripsy system balloon catheter, peripheral

Shockwave M5 - 00195451000157

The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Shockwave Medical, Inc.
5.0 x 60mm
In Commercial Distribution


  • Guidewire Diameter: 0.014 Inch
  • Balloon Nominal (Inflation) Pressure: 6 Atmosphere
  • Balloon Rated Burst Pressure: 10 Atmosphere
  • Balloon Length: 60 Millimeter
  • Balloon Proximal Outer Diameter (OD): 0.064 Inch
  • Catheter Working Length: 110 Centimeter
  • Introducer Sheath Compatibility: 6 French
  • Balloon Diameter: 5.0 Millimeter
M5IVL5060

  • Intravascular lithotripsy system balloon catheter, peripheral

Shockwave M5 - 00195451000133

The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Shockwave Medical, Inc.
4.0 x 60mm
In Commercial Distribution


  • Balloon Diameter: 4.0 Millimeter
  • Guidewire Diameter: 0.014 Inch
  • Balloon Nominal (Inflation) Pressure: 6 Atmosphere
  • Balloon Rated Burst Pressure: 10 Atmosphere
  • Balloon Length: 60 Millimeter
  • Balloon Proximal Outer Diameter (OD): 0.064 Inch
  • Catheter Working Length: 110 Centimeter
  • Introducer Sheath Compatibility: 6 French
M5IVL4060

  • Intravascular lithotripsy system balloon catheter, peripheral

Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter - 00195451000096

The Shockwave C2 Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of the heart to the site of an otherwise difficult to treat calcified stenosis, including calcified stenosis that are anticipated to exhibit resistance to full balloon dilation or subsequent uniform coronary stent expansion. The IVL Catheter contains integrated lithotripsy emitters for the localized delivery of acoustic pressure pulse therapy. The lithotripsy technology generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of the IVL Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2 Catheter is available in four (4) sizes: 2.5x12mm, 3.0x12mm, 3.5x12mm, and 4.0x12mm. The Shockwave C2 is compatible with a 6F guiding catheter and extensions, has a working length of 138cm, and shaft depth markers at the proximal end. The catheter is coated with hydrophilic coating to 22.75 cm from the distal tip to reduce friction during device delivery.
Shockwave Medical, Inc.
3.0 x 12mm
In Commercial Distribution

  • 00195451000096 ()

  • Balloon Diameter: 3.0 Millimeter
  • Balloon Length: 12 Millimeter
  • Catheter Working Length: 138 Centimeter
  • Introducer Sheath Compatibility: 6 French
  • Balloon Proximal Outer Diameter (OD): 0.045 Inch
  • Guidewire Diameter: 0.014 Inch
  • Balloon Nominal (Inflation) Pressure: 6 Atmosphere
  • Balloon Rated Burst Pressure: 10 Atmosphere
C2IVL3012

  • Intravascular lithotripsy system balloon catheter, coronary

Shockwave S4 - 00195451000072

The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The distal catheter and balloon are hydrophilic coated to increase lubricity. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Shockwave Medical, Inc.
4.0 x 40mm
In Commercial Distribution


  • Catheter Working Length: 135 Centimeter
  • Balloon Proximal Outer Diameter (OD): 0.054 Inch
  • Balloon Diameter: 4.0 Millimeter
  • Balloon Length: 40 Millimeter
  • Introducer Sheath Compatibility: 5 French
  • Guidewire Diameter: 0.014 Inch
  • Balloon Nominal (Inflation) Pressure: 6 Atmosphere
  • Balloon Rated Burst Pressure: 10 Atmosphere
S4IVL4040

  • Intravascular lithotripsy system balloon catheter, peripheral

Shockwave M5 - 00195451000188

The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Shockwave Medical, Inc.
6.5 x 60mm
In Commercial Distribution


  • Catheter Working Length: 110 Centimeter
  • Balloon Length: 60 Millimeter
  • Balloon Rated Burst Pressure: 10 Atmosphere
  • Balloon Nominal (Inflation) Pressure: 6 Atmosphere
  • Guidewire Diameter: 0.014 Inch
  • Balloon Proximal Outer Diameter (OD): 0.072 Inch
  • Introducer Sheath Compatibility: 7 French
  • Balloon Diameter: 6.5 Millimeter
M5IVL6560

  • Intravascular lithotripsy system balloon catheter, peripheral

Shockwave M5 - 00195451000171

The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Shockwave Medical, Inc.
6.0 x 60mm
In Commercial Distribution


  • Balloon Diameter: 6.0 Millimeter
  • Guidewire Diameter: 0.014 Inch
  • Balloon Nominal (Inflation) Pressure: 6 Atmosphere
  • Balloon Rated Burst Pressure: 10 Atmosphere
  • Balloon Length: 60 Millimeter
  • Balloon Proximal Outer Diameter (OD): 0.064 Inch
  • Catheter Working Length: 110 Centimeter
  • Introducer Sheath Compatibility: 6 French
M5IVL6060

  • Intravascular lithotripsy system balloon catheter, peripheral

Shockwave M5 - 00195451000164

The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Shockwave Medical, Inc.
5.5 x 60mm
In Commercial Distribution


  • Introducer Sheath Compatibility: 6 French
  • Catheter Working Length: 110 Centimeter
  • Balloon Proximal Outer Diameter (OD): 0.064 Inch
  • Balloon Length: 60 Millimeter
  • Balloon Rated Burst Pressure: 10 Atmosphere
  • Balloon Nominal (Inflation) Pressure: 6 Atmosphere
  • Guidewire Diameter: 0.014 Inch
  • Balloon Diameter: 5.5 Millimeter
M5IVL5560

  • Intravascular lithotripsy system balloon catheter, peripheral
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