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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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The BOND- ADVANCE Terminal provides the computer that contains the software (version 7.0) that controls the processing Module(s). Used to connect to the BOND- ADVANCE Controller in the BOND multi seat configuration (up to amaximum of 30 instruments).
LEICA BIOSYSTEMS MELBOURNE PTY LTD
BOND-ADVANCE Terminal (7.0)
In Commercial Distribution

  • 09349458005528 ()
49.4525

  • Microscope slide stainer IVD
Accessory to the Model 1174 PROFILER 2.
SUN NUCLEAR CORP.
117081Z
In Commercial Distribution

  • B016117081Z0 ()
117081Z

  • Accelerator system quality assurance device
Arrows to indicate the opening direction, pearl-blue
DENTAURUM GmbH & Co.KG
611-132-00
In Commercial Distribution

  • J011611132000 ()
  • J011611132001 ()


  • Orthodontic palate expander screw, self-removable
Arrows to indicate the opening direction, white
DENTAURUM GmbH & Co.KG
611-131-00
In Commercial Distribution

  • J011611131000 ()
  • J011611131001 ()


  • Orthodontic palate expander screw, self-removable
Arrows to indicate the opening direction, yellow
DENTAURUM GmbH & Co.KG
611-130-00
In Commercial Distribution

  • J011611130000 ()
  • J011611130001 ()


  • Orthodontic palate expander screw, self-removable
Belt to reposition the patient on Armchair
MEDI CARE SYSTEM SLU
SCC4406
In Commercial Distribution

  • 08436035357178 ()
  • 08436035357161 ()


  • Wheelchair/chair/stander occupant restraint/support
Belt to reposition the patient on Armchair
MEDI CARE SYSTEM SLU
SCC4405
In Commercial Distribution

  • 08436035357154 ()
  • 08436035357147 ()


  • Wheelchair/chair/stander occupant restraint/support
Dedo Extension mounts to the rectangular-sided support
Hayden Medical, Inc.
202-108
In Commercial Distribution

  • 00840319743072 ()
202-108

  • Frame/rail/pole device holder
The Superhero :Black-Red :Black to Grey :Rubber
IC! Berlin America LLC
00190064094142
In Commercial Distribution

  • 00190064094142 ()


  • Tinted non-prescription spectacles
To support the 7.x software version
Philips Ultrasound LLC
795125
In Commercial Distribution

  • 00884838109971 ()


  • General-purpose ultrasound imaging system
Head Phones Slim is part of NordicNeuroLab’s Audio System. The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient wearing a set of headphones. A communication console allows the operator to adjust the sounds from the PC and to speak directly to the patient through a built-in microphone. The Head Phone Slim is designed specifically for use in the MR environment, and are compatible with MR system up to 3T.
Nordicneurolab AS
HPS 1.0
Not in Commercial Distribution

  • 07090042053020 ()


  • Auditory stimulator
Head Phones is part of NordicNeuroLab’s Audio System. The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient wearing a set of headphones. A communication console allows the operator to adjust the sounds from the PC and to speak directly to the patient through a built-in microphone. The Head Phone is designed specifically for use in the MR environment, and are compatible with MR system up to 3T.
Nordicneurolab AS
HP 1.3
In Commercial Distribution

  • 07090042053013 ()


  • Auditory stimulator
Fluorescence imaging system
FLUOPTICS
FBLXR
In Commercial Distribution

  • B475FBLXR0 ()


  • Intraoperative parathyroid detection system control unit
  • Diagnostic-imaging multiformat camera
Fluorescence imaging system
FLUOPTICS
FBLX
In Commercial Distribution

  • B475FBLX0 ()


  • Diagnostic-imaging multiformat camera
  • Intraoperative parathyroid detection system control unit
The HidraWear AX device is a garment device, which is intended for the retention of a dressing in the axillar area. The HidraMed AX is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn over a brassiere and is then applied to the axillar area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care. Size: Extra Extra Large
HIDRAMED SOLUTIONS LIMITED
GAX001-05
In Commercial Distribution

  • 05391535510092 ()


  • Non-adhesive device retention bandage
The HidraWear AX device is a garment device, which is intended for the retention of a dressing in the axillar area. The HidraMed AX is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn over a brassiere and is then applied to the axillar area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care. Size: Extra Large
HIDRAMED SOLUTIONS LIMITED
GAX001-04
In Commercial Distribution

  • 05391535510030 ()


  • Non-adhesive device retention bandage
The HidraWear AX device is a garment device, which is intended for the retention of a dressing in the axillar area. The HidraMed AX is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn over a brassiere and is then applied to the axillar area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care. Size: Large
HIDRAMED SOLUTIONS LIMITED
GAX001-03
In Commercial Distribution

  • 05391535510023 ()


  • Non-adhesive device retention bandage
The HidraWear AX device is a garment device, which is intended for the retention of a dressing in the axillar area. The HidraMed AX is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn over a brassiere and is then applied to the axillar area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care. Size: Medium
HIDRAMED SOLUTIONS LIMITED
GAX001-02
In Commercial Distribution

  • 05391535510016 ()


  • Non-adhesive device retention bandage
The HidraWear AX device is a garment device, which is intended for the retention of a dressing in the axillar area. The HidraMed AX is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn over a brassiere and is then applied to the axillar area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care. Size: Small
HIDRAMED SOLUTIONS LIMITED
GAX001-01
In Commercial Distribution

  • 05391535510009 ()


  • Non-adhesive device retention bandage
The Sensonics 16-item odor identification test is a member of the Snap & Sniff® Olfactory Testing System family. This test, along with the other members of the family, was developed to provide scientists, clinicians, and others with a standardized, easy-to-use, and reliable means for evaluating the ability of subjects to identify odors. Detailed instructions are provided in an accompanying manual to acquaint the test administrator with the details of proper test administration. The test employs the following familiar odorants: mint, lemon, leather, banana, orange, paint thinner, garlic, licorice, cloves, pineapple, apple, rose, coffee, fish, cinnamon, and chocolate. The S&S-I is comprised of 16 smell “wands”. The odor of a given wand is contained within a proprietary odor emitting cartridge. When the thumb of the operator pushes forward on a slide mechanism, the odorized tip is exposed for sampling and presented to the subject. Releasing the slide retracts the odorized tip back into the wand’s housing. The Snap & Sniff® mechanism results in an easy presentation of an odorant to a subject. Because the odorant tip is presented only briefly, the odor is retained for much longer periods and can be used for testing many more subjects than devices lacking such sophisticated technology. Liquids, per se, are not present in the sniff wands.
Sensonics, Inc.
SSI
In Commercial Distribution

  • G051SSI0 ()


  • Olfactory test stick
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