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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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AIMING DEVICE FOR 12MM SYNFIX-LR
SYNTHES (U.S.A.) LP
03.802.020
Not in Commercial Distribution

  • 07611819973091 ()
  • H981038020200 ()
  • 10705034722153 ()
03802020

  • Orthopaedic implant aiming/guiding block, reusable
The BellaVisage Hybrid is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV. The Silk'n BellaVisage Hybrid is designed as a hand-held device, battery operated which utilizes both Bi-Polar RF and low power light energies. The device includes RF generator, LEDs at wavelengths of 630±20nm and 850±20nm (Red and IR wavelengths, respectively) and a temperature stabilizer. The device consists of an applicator and an adaptor. The applicator is a handheld unit used for treatment. The device has a treatment surface with 3 electrodes and a control button with 4 surrounding indicator lights. The device has a rechargeable battery for cordless use, as well as an adapter for connection to the mains.
HOME SKINOVATIONS LTD
BellaVisage Hybrid
In Commercial Distribution

  • 17290112452013 ()
  • 07290112452016 ()
7290112452016

  • Radio-frequency skin surface treatment system
The Silk'n Titan Allways is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV. The Silk'n Titan Allways is designed as a hand-held device, battery operated which utilizes both Bi-Polar RF and low power light energies. The device includes RF generator, LEDs at wavelengths of 630±20nm and 850±20nm (Red and IR wavelengths, respectively) and a temperature stabilizer. The Silk'n Titan AllWays device consists of an applicator and an adaptor. The applicator is a handheld unit used for treatment. The device has a treatment surface with 3 electrodes and a control button with 4 surrounding indicator lights. The device has a rechargeable battery for cordless use, as well as an adapter for connection to the mains.
HOME SKINOVATIONS LTD
Titan AllWays
In Commercial Distribution

  • 17290112451559 ()
  • 07290112451552 ()
7290112451552

  • Radio-frequency skin surface treatment system
The Silk'n device ia an over-the-counter, non-invasive, non-ablative device utilizing RF and optical LED energies for the treatment of wrinkles.
HOME SKINOVATIONS LTD
BellaVisage
In Commercial Distribution

  • 17290112450224 ()
  • 07290112450227 ()
  • 27290112450221 ()
7290112450227

  • Radio-frequency skin surface treatment system
The Silk'n device ia an over-the-counter, non-invasive, non-ablative device utilizing RF and optical LED energies for the treatment of wrinkles.
HOME SKINOVATIONS LTD
Titan
In Commercial Distribution

  • 07290015763851 ()
  • 17290015763858 ()
  • 27290015763855 ()
7290015763851

  • Radio-frequency skin surface treatment system
5mm x 32cm Cannula with Holes, Reusable
Conmed Corporation
CD860
In Commercial Distribution

  • 30653405046367 ()
  • 20653405046360 ()

  • Outer Diameter: 10 Millimeter
  • Length: 32 Centimeter
CD860

  • Rigid endoscopic cannula, reusable
5mm x 45cm Cannula with Holes, Reusable
Conmed Corporation
CD849
In Commercial Distribution

  • 30653405046282 ()
  • 20653405046285 ()

  • Outer Diameter: 5 Millimeter
  • Length: 45 Centimeter
CD849

  • Rigid endoscopic cannula, reusable
Pulsewave Pump
Cardinal Health 200, LLC
ASU1145
In Commercial Distribution

  • 10885380003530 ()
  • 50885380003538 ()
ASU1145

  • Surgical irrigation/aspiration system pump
HALL OSTEON STRAIGHT HANDPIECE
Conmed Corporation
5038-001
Not in Commercial Distribution

  • 20845854023201 ()
  • 30845854023208 ()
00503800100

  • Surgical power tool system handpiece, sawing, pneumatic
HALL OSTEON ANGLED HANDPIECE
Conmed Corporation
5038-002
Not in Commercial Distribution

  • 20845854023218 ()
  • 30845854023215 ()
00503800200

  • Surgical power tool system handpiece, sawing, pneumatic
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