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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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Silicone pressure sensitive adhesive in hexamethyldisiloxane. 2oz bottle with spray top.
Delta Molding LLC
SA2S
In Commercial Distribution

  • 00810049490652 ()


  • Skin surface device adhesive
Silicone pressure sensitive adhesive in hexamethyldisiloxane. 4oz bottle with spray top.
Delta Molding LLC
SA4S
In Commercial Distribution

  • 00810049490645 ()


  • Skin surface device adhesive
No Description
Omay(Guangzhou) Med Technologies Co.,Ltd
Omay-A
In Commercial Distribution

  • 06975435800058 ()


  • External counterpulsation system, stationary
No Description
KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITED
SSU-2
In Commercial Distribution

  • 15019778005386 ()


  • General-purpose suction system, line-powered
No Description
KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITED
SSU-2
In Commercial Distribution

  • 15019778005140 ()


  • General-purpose suction system, line-powered
No Description
Vista Dental
9007100
In Commercial Distribution

  • 10818207025040 ()


  • Dental restoration fixation cleaning solution
Lid-Chain Berghaus/Schrom 2.0GM
JEDMED INSTRUMENT COMPANY
28-1520
In Commercial Distribution

  • M6332815200 ()

  • Weight: 2.0 Kilogram
28-1520

  • Eyelid weight, implantable
Non-sterile reusable autoinjector device, with an external indicator, for the injection of FDA-approved drugs from fixed needle syringes
OWEN MUMFORD LIMITED
AJ1310
In Commercial Distribution

  • 00384701310010 ()
  • 00384701310034 ()

  • Width: 25 Millimeter
  • Length: 210 Millimeter
AJ1310

  • Syringe-loaded medication/vaccine injector, manual, professional
No Description
BIOINFINITY (M) SDN. BHD.
VPT-700
In Commercial Distribution

  • 09555860800006 ()

  • Outer Diameter: 22 Millimeter
  • Length: 60 Millimeter


  • Perineometer
The PeriCoach is a perineometer designed to treat stress, mild-moderate urge and mixed urinary incontinence in women, by strengthening of the pelvic floor muscles through exercise. This device provides biofeedback via smart phone technology. The PeriCoach® device consists of a rigid probe covered in a silicone sheath that is temporarily inserted into the vagina. Sensors located under the sheath measure the strength of contraction of the user’s pelvic floor muscles. This information is then transmitted wirelessly to a smartphone application in order to provide real-time feedback to the user. It is a single patient, reusable device.
STRATOS MEDTECH PTY LTD
PC0100
In Commercial Distribution

  • 09338067000581 ()


  • Perineometer
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