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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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CROSSTELLA RX - 04540778157552

CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-F60020MR
In Commercial Distribution

  • 04540778157552 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.4 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 6.0 mm
BD-F60020MR

  • Peripheral angioplasty balloon catheter, basic

CROSSTELLA RX - 04540778157538

CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-F50020MR
In Commercial Distribution

  • 04540778157538 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.4 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 5.0 mm
BD-F50020MR

  • Peripheral angioplasty balloon catheter, basic

CROSSTELLA RX - 04540778157514

CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-F40020MR
In Commercial Distribution

  • 04540778157514 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.4 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 4.0 mm
BD-F40020MR

  • Peripheral angioplasty balloon catheter, basic

CROSSTELLA RX - 04540778157491

CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-F30020MR
In Commercial Distribution

  • 04540778157491 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.4 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 3.0 mm
BD-F30020MR

  • Peripheral angioplasty balloon catheter, basic

CROSSTELLA RX - 04540778157477

CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-F25020MR
In Commercial Distribution

  • 04540778157477 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.4 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 2.5 mm
BD-F25020MR

  • Peripheral angioplasty balloon catheter, basic

CROSSTELLA RX - 04540778157453

CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-F20020MR
In Commercial Distribution

  • 04540778157453 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.4 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 2.0 mm
BD-F20020MR

  • Peripheral angioplasty balloon catheter, basic

Velacur - B995LI10050

Velacur is a portable ultrasonic elastography machine used to assess and monitor chronic liver diseases. The device is comprised of a control unit, activation unit, and ultrasound probe. A carrying case is also provided.
Sonic Incytes Medical Corp.
LI-1005
In Commercial Distribution

  • B995LI10050 ()


  • Hepatic ultrasound elastography system

GammaZyme-F - 10888234000709

GammaZyme-F is used in two-stage (pretreatment of red blood cells) enzyme test systems for blood group antibody detection. GammaZyme-F is a stabilized solution of ficin, and this product is in a single vial configuration.
IMMUCOR, INC.
0007056
In Commercial Distribution

  • 10888234000709 ()
0007056

  • Ficin immunohaematology reagent IVD

MD-Temp(White) - 08806387892137

MD-Temp is a temporary resin for formation of temporary fillings, and other temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated. It is a hydraulic temporary restorative.
Meta Biomed Co., Ltd.
9213
In Commercial Distribution

  • 08806387892137 ()


  • Temporary dental crown/bridge

MD-Temp(Pink) - 08806387892120

MD-Temp is a temporary resin for formation of temporary fillings, and other temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated. It is a hydraulic temporary restorative.
Meta Biomed Co., Ltd.
9212
In Commercial Distribution

  • 08806387892120 ()


  • Temporary dental crown/bridge

CROSSTELLA RX - 04540778160439

CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-F60200ER
In Commercial Distribution

  • 04540778160439 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 5 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 4.1 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 2000 mm
  • Balloon Length; 200 mm
  • Balloon Diameter; 6.0 mm
BD-F60200ER

  • Peripheral angioplasty balloon catheter, basic

CROSSTELLA RX - 04540778160415

CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-F50200ER
In Commercial Distribution

  • 04540778160415 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 5 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 4.1 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 2000 mm
  • Balloon Length; 200 mm
  • Balloon Diameter; 5.0 mm
BD-F50200ER

  • Peripheral angioplasty balloon catheter, basic

CROSSTELLA RX - 04540778160392

CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-F40200ER
In Commercial Distribution

  • 04540778160392 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.4 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 2000 mm
  • Balloon Length; 200 mm
  • Balloon Diameter; 4.0 mm
BD-F40200ER

  • Peripheral angioplasty balloon catheter, basic

CROSSTELLA RX - 04540778160378

CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-F30200ER
In Commercial Distribution

  • 04540778160378 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.4 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 2000 mm
  • Balloon Length; 200 mm
  • Balloon Diameter; 3.0 mm
BD-F30200ER

  • Peripheral angioplasty balloon catheter, basic

CROSSTELLA RX - 04540778160354

CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-F25200ER
In Commercial Distribution

  • 04540778160354 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.4 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 2000 mm
  • Balloon Length; 200 mm
  • Balloon Diameter; 2.5 mm
BD-F25200ER

  • Peripheral angioplasty balloon catheter, basic

CROSSTELLA RX - 04540778160330

CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-F20200ER
In Commercial Distribution

  • 04540778160330 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.4 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 2000 mm
  • Balloon Length; 200 mm
  • Balloon Diameter; 2.0 mm
BD-F20200ER

  • Peripheral angioplasty balloon catheter, basic

CROSSTELLA RX - 04540778160316

CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-F60150ER
In Commercial Distribution

  • 04540778160316 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 5 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 4.1 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 2000 mm
  • Balloon Length; 150 mm
  • Balloon Diameter; 6.0 mm
BD-F60150ER

  • Peripheral angioplasty balloon catheter, basic

CROSSTELLA RX - 04540778160293

CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-F50150ER
In Commercial Distribution

  • 04540778160293 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 5 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 4.1 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 2000 mm
  • Balloon Length; 150 mm
  • Balloon Diameter; 5.0 mm
BD-F50150ER

  • Peripheral angioplasty balloon catheter, basic

CROSSTELLA RX - 04540778160279

CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-F40150ER
In Commercial Distribution

  • 04540778160279 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.4 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 2000 mm
  • Balloon Length; 150 mm
  • Balloon Diameter; 4.0 mm
BD-F40150ER

  • Peripheral angioplasty balloon catheter, basic

CROSSTELLA RX - 04540778160255

CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-F30150ER
In Commercial Distribution

  • 04540778160255 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.4 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 2000 mm
  • Balloon Length; 150 mm
  • Balloon Diameter; 3.0 mm
BD-F30150ER

  • Peripheral angioplasty balloon catheter, basic

CROSSTELLA RX - 04540778160231

CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-F25150ER
In Commercial Distribution

  • 04540778160231 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.4 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 2000 mm
  • Balloon Length; 150 mm
  • Balloon Diameter; 2.5 mm
BD-F25150ER

  • Peripheral angioplasty balloon catheter, basic

Genotropin Mixer® - 10300130923796

The Genotropin Mixer is a device used to mix growth hormone that is provided in a Two-Chamber Cartridge (TCC). The Genotropin Mixer is a non-sterile, reusable medical device designed for mixing the Genotropin TCC.
PFIZER INC.
F000092379
In Commercial Distribution

  • 10300130923796 ()


  • Basic growth hormone autoinjector, replaceable-cartridge

BRAEBON MediByte - B140MP8WN0

The MediByte is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. This is a new warranty replacement unit.
Braebon Medical Corporation
MP8-WN
In Commercial Distribution

  • B140MP8WN0 ()
MP8-WN

  • Polysomnograph

BRAEBON MediByte Jr. - B140MBJRW0

The MediByte Jr. is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. This is a warranty replacement unit.
Braebon Medical Corporation
MBJR-W
In Commercial Distribution

  • B140MBJRW0 ()
MBJR-W

  • Polysomnograph

Allen key 3.5 mm - 07640187910476

Allen key 3.5 mm is a hand-held instrument used to hold or unhold screw on the extraction clamp and the chisel handle. This is a hexagonal tip of 3.5 mm.This is a reusable device.
MPS Micro Precision Systems AG
T14927
In Commercial Distribution

  • 07640187910476 ()
T14927

  • Surgical screwdriver, reusable

Smart CapnoLine / Microstream - 20884838071050

Material on this Purchase Order is managed via SMI. The delivery schedule is determined by the Supplier per the SMI stocking limits and not by this Purchase Order. Quantity shown is for reference only.
Philips Medical Systems Hsg
Smart CapnoLine H O2 Adult
Not in Commercial Distribution

  • 20884838071050 ()
  • 00884838071056 ()
989803177951

  • Nasal oxygen cannula, carbon-dioxide-sampling

SuperPole™ FRS Pole - 00689281005128

The SuperPole F.R.S. is a high quality, commercial grade support pole that interfaces with and is supported by a receptacle that is permanently embedded into a structural concrete floor. The SuperPole F.R.S. is intended for moderate vertical load bearing to provide sitting and standing support for people with reduced mobility. When the pole is removed, the receptacle must be covered with a floor flush cap to provide a water-tight seal. The maximum user weight for this product is 450lbs / 205kgs. Product is not intended to support full body weight. The SuperPole F.R.S. is not to be used in any other way than described
Healthcraft Products Inc.
FRS-P
In Commercial Distribution

  • 00689281005128 ()
00512

  • Fixed-rail armrest

Parasym - 06942808291027

Parasym is a Transcutaneous Electrical Nerve Stimulator, which is used to provide symptomatic pain relief for chronic, acute or post operative pain.
EasyMed Instruments Co., Ltd.
Parasym
Not in Commercial Distribution

  • 06942808291027 ()


  • Analgesic transcutaneous electrical nerve stimulation system

MT-11 - 06942808221109

MT-11 is a Transcutaneous Electrical Nerve Stimulator, which is used to provide symptomatic pain relief for chronic, acute or post operative pain.
EasyMed Instruments Co., Ltd.
MT-11
Not in Commercial Distribution

  • 06942808221109 ()


  • Analgesic transcutaneous electrical nerve stimulation system

PowerTENS - 06942808221093

PowerTENS is a Transcutaneous Electrical Nerve Stimulator, which is used to provide symptomatic pain relief for chronic, acute or post operative pain.
EasyMed Instruments Co., Ltd.
PowerTENS
In Commercial Distribution

  • 06942808221093 ()


  • Analgesic transcutaneous electrical nerve stimulation system
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