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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 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
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 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
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
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
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
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
The LED Light Therapy Mask (Model:MK66R-B) is an over-the-counter device that is intended for the use in the treatment of full-face wrinkles.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
MK66R-B
In Commercial Distribution

  • 00655729008235 ()


  • Cosmetic red-light phototherapy system, home-use
Syringe with Safety Needle is Luer Lock syringe with hinged-cap safety needle. This device is used for aspiration and administration of medication.
HTL STREFA S A
1mL 25Gx1”
In Commercial Distribution

  • 05903999600327 ()
  • 15903999600324 ()
  • 25903999600321 ()
6073

  • General-purpose syringe/needle
  • Needle guard
Syringe with Safety Needle is Luer Lock syringe with hinged-cap safety needle. This device is used for aspiration and administration of medication.
HTL STREFA S A
3mL 25Gx1”
In Commercial Distribution

  • 05903999600310 ()
  • 15903999600317 ()
  • 25903999600314 ()
6072

  • General-purpose syringe/needle
  • Needle guard
Model WL-2407Rx is a portable, battery-powered, transcutaneous electrical nerve stimulator (TENS device) that is intended for symptomatic relief of chronic intractable pain.
WELL-LIFE HEALTHCARE LTD.
WL-2407Rx
Not in Commercial Distribution

  • 04719872264088 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered
The 50EW is a rechargeable pulse oximeter that is designed to accurately measure oxygen saturation (SpO2) and pulse rate through your finger.
LORTE TECHNOLOGIES, INC
CMS-50EW with Bluetooth
In Commercial Distribution

  • 00851908007062 ()


  • Pulse oximeter
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 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 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
Capture-P solid phase system is intended for use in the detection of antibodies to platelets. This is the five (5) microplate product.
IMMUCOR, INC.
0066251
In Commercial Distribution

  • 10888234001300 ()
0066251

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, agglutination
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. 9 gram Light Gel Etch Bottle. Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-023 B
In Commercial Distribution

  • D801SP65023B1 ()
65-023

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. 9 gram Light Gel Etch Bottle. Non-Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-023
In Commercial Distribution

  • D801SP650231 ()
65-023

  • Dentine adhesive
Stainless Steel Ortho FlexTech Lingual Retention System is intended for use as a Lingual Retainer Wire. This is the Stainless Steel version.
RELIANCE ORTHODONTIC PRODUCTS INC
SSOFT
In Commercial Distribution

  • D798SSOFTSAM0 ()
SSOFT

  • Orthodontic retainer
Stainless Steel Ortho FlexTech Lingual Retention System is intended for use as a Lingual Retainer Wire. This is the Stainless Steel version.
RELIANCE ORTHODONTIC PRODUCTS INC
SSOFT
In Commercial Distribution

  • D798SSOFT0 ()
SSOFT

  • Orthodontic retainer
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