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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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Bovie - 00887482176948

Grounding Plate A1200
SYMMETRY SURGICAL INC.
A1204P
In Commercial Distribution

  • 00887482176948 ()


  • Electrosurgical return electrode, reusable

Bovie - 00887482176931

Reusable Cord For Reusable Grounding Plate
SYMMETRY SURGICAL INC.
A1204C
In Commercial Distribution

  • 00887482176931 ()


  • Electrosurgical return electrode, reusable

Bovie - 00887482176924

Grounding Plate With Cord
SYMMETRY SURGICAL INC.
A1204
In Commercial Distribution

  • 00887482176924 ()


  • Electrosurgical return electrode, reusable

Bovie - 00887482176894

Reusable Cable Grounding Pad
SYMMETRY SURGICAL INC.
A1202C
In Commercial Distribution

  • 00887482176894 ()


  • Electrosurgical return electrode, reusable

Silk'n - 17290112452013

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

Silk'n - 17290112451559

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

Silk'n - 17290112450224

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

Bovie - 00887482181201

Disp Solid Adult Return Electrode w/3M Cable 50/bx
SYMMETRY SURGICAL INC.
ESRSC
In Commercial Distribution

  • 00887482181218 ()
  • 00887482181201 ()


  • Electrosurgical return electrode, single-use

Bovie - 00887482181188

Return Solid Pads Disposable Bx/50
SYMMETRY SURGICAL INC.
ESRS
In Commercial Distribution

  • 00887482181195 ()
  • 00887482181188 ()


  • Electrosurgical return electrode, single-use

Bovie - 00887482181164

Disp Split Adult Return Electrode w/3M Cable 50/bx
SYMMETRY SURGICAL INC.
ESREC
In Commercial Distribution

  • 00887482181171 ()
  • 00887482181164 ()


  • Electrosurgical return electrode, single-use

MR Introducer - 17340007000956

No Description
Clinical Laserthermia Systems AB
4013-N6
In Commercial Distribution

  • 37340007000950 ()
  • 17340007000956 ()
  • 57340007000954 ()


  • General/multiple surgical laser system beam guide, reusable

Instructions for Use Laser applicator - Neuro - 17340007000888

No Description
Clinical Laserthermia Systems AB
L-2022-075
In Commercial Distribution

  • 17340007000888 ()


  • General/multiple surgical laser system beam guide, reusable

Laser Applicator Non-cooled - 17340007000864

No Description
Clinical Laserthermia Systems AB
4017-N4
In Commercial Distribution

  • 37340007000868 ()
  • 17340007000864 ()


  • General/multiple surgical laser system beam guide, reusable

Laser Applicator Non-cooled - 17340007000857

No Description
Clinical Laserthermia Systems AB
4017-N2
In Commercial Distribution

  • 37340007000851 ()
  • 17340007000857 ()


  • General/multiple surgical laser system beam guide, reusable

Laser Applicator Non-cooled - 17340007000840

No Description
Clinical Laserthermia Systems AB
4012-N5
In Commercial Distribution

  • 37340007000844 ()
  • 17340007000840 ()


  • General/multiple surgical laser system beam guide, reusable

MR Introducer - 17340007000789

No Description
Clinical Laserthermia Systems AB
4013-16
In Commercial Distribution

  • 37340007000783 ()
  • 17340007000789 ()
  • 57340007000787 ()


  • General/multiple surgical laser system beam guide, reusable

MR Introducer - 17340007000772

No Description
Clinical Laserthermia Systems AB
4013-15
In Commercial Distribution

  • 37340007000776 ()
  • 17340007000772 ()
  • 57340007000770 ()


  • General/multiple surgical laser system beam guide, reusable

MR Introducer - 17340007000765

No Description
Clinical Laserthermia Systems AB
4013-14
In Commercial Distribution

  • 37340007000769 ()
  • 17340007000765 ()
  • 57340007000763 ()


  • General/multiple surgical laser system beam guide, reusable

Instructions for Use Laser applicator - US - 17340007000734

No Description
Clinical Laserthermia Systems AB
L-2018-060
In Commercial Distribution

  • 17340007000734 ()


  • General/multiple surgical laser system beam guide, reusable

MR Stylet - 17340007000604

No Description
Clinical Laserthermia Systems AB
4013-13
In Commercial Distribution

  • 37340007000608 ()
  • 17340007000604 ()
  • 57340007000602 ()


  • General/multiple surgical laser system beam guide, reusable

MR Catheter - 17340007000598

No Description
Clinical Laserthermia Systems AB
4013-12
In Commercial Distribution

  • 37340007000592 ()
  • 17340007000598 ()
  • 57340007000596 ()


  • General/multiple surgical laser system beam guide, reusable

MR Stylet - 17340007000581

No Description
Clinical Laserthermia Systems AB
4013-11
In Commercial Distribution

  • 37340007000585 ()
  • 17340007000581 ()
  • 57340007000589 ()


  • General/multiple surgical laser system beam guide, reusable

MR Catheter - 17340007000574

No Description
Clinical Laserthermia Systems AB
4013-10
In Commercial Distribution

  • 37340007000578 ()
  • 17340007000574 ()
  • 57340007000572 ()


  • General/multiple surgical laser system beam guide, reusable

MR Stylet - 17340007000567

No Description
Clinical Laserthermia Systems AB
4013-08
In Commercial Distribution

  • 37340007000561 ()
  • 17340007000567 ()
  • 57340007000565 ()


  • General/multiple surgical laser system beam guide, reusable

Laser Applicator Non-cooled Instructions for Use - 17340007000529

No Description
Clinical Laserthermia Systems AB
L-2016-055
In Commercial Distribution

  • 17340007000529 ()


  • General/multiple surgical laser system beam guide, reusable

Laser Applicator Non-cooled Instructions for Use - 17340007000505

No Description
Clinical Laserthermia Systems AB
L-2015-049
In Commercial Distribution

  • 17340007000505 ()


  • General/multiple surgical laser system beam guide, reusable

Laser Applicator Non-cooled - 17340007000499

No Description
Clinical Laserthermia Systems AB
4012-05
In Commercial Distribution

  • 57340007000497 ()
  • 37340007000493 ()
  • 17340007000499 ()


  • General/multiple surgical laser system beam guide, reusable

Laser Applicator Non-cooled - 17340007000468

No Description
Clinical Laserthermia Systems AB
4017-02
In Commercial Distribution

  • 57340007000466 ()
  • 37340007000462 ()
  • 17340007000468 ()


  • General/multiple surgical laser system beam guide, reusable

Laser Applicator Non-cooled - 17340007000451

No Description
Clinical Laserthermia Systems AB
4017-01
In Commercial Distribution

  • 57340007000459 ()
  • 37340007000455 ()
  • 17340007000451 ()


  • General/multiple surgical laser system beam guide, reusable

Laser Applicator Non-cooled - 17340007000284

No Description
Clinical Laserthermia Systems AB
4017-04
In Commercial Distribution

  • 37340007000288 ()
  • 17340007000284 ()


  • General/multiple surgical laser system beam guide, reusable
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