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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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RevLight is a device that utilizes Light Emitting Diodes to provide LED light to the body. The base unit contains the power supplies, the control unit, and sets of Pulsators that deliver the light to the skin. The output of the Pulsators ranges from 420-940nm. RevLight is intended for use to provide LED light to the body. Depending on the wavelength(s) of light delivered by the Pulsators, RevLight is: 1. generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris (Blue Pulsators); and 2. generally indicated to provide topical heating to promote increased blood flow, relaxation of muscle and relief of pain (Amber/Red Pulsators).
SUBCON MANUFACTURING CORP
1030
Not in Commercial Distribution

  • B82110300 ()
1030

  • Cosmetic red-light phototherapy system, professional
RevLight is a device that utilizes Light Emitting Diodes to provide LED light to the body. The base unit contains the power supplies, the control unit, and sets of Pulsators that deliver the light to the skin. The output of the Pulsators ranges from 420-940nm. RevLight is intended for use to provide LED light to the body. Depending on the wavelength(s) of light delivered by the Pulsators, RevLight is: 1. generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris (Blue Pulsators); and 2. generally indicated to provide topical heating to promote increased blood flow, relaxation of muscle and relief of pain (Amber/Red Pulsators).
SUBCON MANUFACTURING CORP
1000
Not in Commercial Distribution

  • B82110000 ()
1000

  • Cosmetic red-light phototherapy system, professional
RevLight is a device that utilizes Light Emitting Diodes to provide LED light to the body. The base unit contains the power supplies and the control unit. Attachable to the base unit are three sets of Pulsators that deliver the light to the skin as they are moved over the skin surface. The output of the Pulsators ranges from 420-940nm. RevLight is intended for use to provide LED light to the body. Depending on the wavelength(s) of light delivered by the detachable Pulsators that are connected to the base unit, RevLight is: 1. generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris (Blue Pulsators); and 2. generally indicated to provide topical heating to promote increased blood flow, relaxation of muscle and relief of pain (Amber/Red Pulsators).
SUBCON MANUFACTURING CORP
1029
Not in Commercial Distribution

  • B82110290 ()
1029

  • Cosmetic red-light phototherapy system, professional
The Reference Viscosity Oil QC test is a simple means of verifying proper operation of the Sonoclot Analyzer. This test consists of a two point verification of the electromechanical oscillator and also ensures that the heating control is operating accurately. The two verification points are: 1) Probe-In-Air, and 2) Probe-In-Oil. The Probe-In-Air is the response of the electromechanical oscillator to air. The Probe-In-Oil is the response of the electromechanical oscillator to the reference viscosity liquid. Since the viscosity of the reference viscosity fluid is significantly temperature dependent, the Probe-In-Oil test point also verifies the temperature regulation. The QC test should be run each day the Sonoclot Analyzer is used or as required by your institution. Each Reference Viscosity Quality Control Kit contains 24 cuvettes, 24 probes, 1 vial of reference viscosity oil with end cap, and these instructions. These supplies provide 24 QC tests for the analyzer.
SIENCO, INC.
900-1302
In Commercial Distribution

  • B55890013020 ()
  • B55890013021 ()
900-1302

  • Multiple coagulation factor IVD, control
Cleaning Brush Kit - SuperDART® ONE PASS™ ECCD 9292 Plus SW Cylinder Brush 9990, HIBC/UPN: M45391882
Primed Instruments Inc
9188
In Commercial Distribution

  • 00666416120840 ()
  • M45391882 ()
  • 00666416120857 ()
9188-25

  • Surgical instrument/endoscope cleaning utensil, single-use
SuperDART® ONE PASS™ Validated Pull Through Three Stage Channel Cleaning Device. HIBC/UPN: M45392922
Primed Instruments Inc
9292
In Commercial Distribution

  • 00666416120772 ()
  • M45392922 ()
  • 00666416120758 ()

  • Range of Channel Size: 2.8-4.2mm
  • Length: 250 Centimeter
  • Minimum Channel Size 2.0mm
  • Brush Diameter: 3-6.3mm
  • Overall Length: 240cm
9292-25

  • Surgical instrument/endoscope cleaning utensil, single-use
Cleaning Brush Kit - 9992 Valve and Suction Well Cleaning Brush & 9192 Double Ended Channel Cleaning Brush. HIBC/UPN: M45391223
Primed Instruments Inc
9122
In Commercial Distribution

  • 00666416120383 ()
  • 00666416120505 ()
  • M45391223 ()
9122-50

  • Surgical instrument/endoscope cleaning utensil, single-use
Disposable Channel Cleaning Micro Brush. HIBC/UPN: M45391155
Primed Instruments Inc
9115
In Commercial Distribution

  • 00666416120338 ()
  • 00666416120420 ()
  • M45391155 ()

  • Minimum Channel Size: 2.0mm
  • Tapered Brush Diameter: 3.0-5.0mm
  • Overall Length: 115cm
9115-100

  • Surgical instrument/endoscope cleaning utensil, single-use
Disposable Channel Cleaning Micro Brush. HIBC/UPN: M45390252
Primed Instruments Inc
9025
Not in Commercial Distribution

  • 00666416120314 ()
  • 00666416120413 ()
  • M45390252 ()

  • Minimum Channel Size: 1.2mm
  • Brush Diameter: 2.5mm
  • Overall Length: 120cm
9025-25

  • Surgical instrument/endoscope cleaning utensil, single-use
Disposable Channel Cleaning Micro Brush. HIBC/UPN: M45391153
Primed Instruments Inc
9115
In Commercial Distribution

  • 00666416120079 ()
  • 00666416120420 ()
  • M45391153 ()

  • Minimum Channel Size: 2.0mm
  • Tapered Brush Diameter: 3.0-5.0mm
  • Overall Length: 115cm
9115-50

  • Surgical instrument/endoscope cleaning utensil, single-use
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