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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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Beijing Nubway S&T Co., Ltd.
QLHF-02
In Commercial Distribution

  • 06971679500020 ()


  • Dermatological laser beam guiding handpiece
The Dual Yellow laser is indicated for the treatment of benign pigmented and cutaneous vascular lesions. The Dual Yellow laser, operating at 578 nm, is indicated in dermatology, plastic surgery, and general surgery for treatment of benign cutaneous vascular lesions including but not limited to: Treatment of wrinkles, Periocular wrinkles, Periorbital wrinkles. Facial and leg telangiectasia, Rosacea, Cherry angiomas, Port wine stains, Hemangiomas and venous lakes, Angioma, Spider angioma, and Poikiloderma of Civatte, Inflammatory Acne Vulgaris, Verrucae/Warts, Scars, Striea, and Psoriasis. Podiatry - for benign cutaneous lesions and warts. The Dual Yellow lase, operating at 511 rn, is indicated in dermatology, plastic surgery, and general surgery for treatment of benign cutaneous pigmented lesions including but not limited to: Lentigines, Solar keratoses, Adenoma serabaceum, Skin tabs, Trichoepitheliomas (benign lesions similar to skin tags) Naevi, Keratoses, Syringomas Seborrhoeic keratoses Verrucae vulgaris, and Warts.
NORSELD PTY. LIMITED
D10B Dual Yellow
In Commercial Distribution

  • B241D10B0 ()


  • Dermatological laser beam guiding handpiece
External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima
SYNERON MEDICAL LTD
KT77911
Not in Commercial Distribution

  • 17290109952823 ()
  • 07290109952888 ()


  • Dermatological laser beam guiding handpiece
Regular Internal Handpiece 5-Pack Sterile Single-Use, CO2RE Intima
SYNERON MEDICAL LTD
KT77821
Not in Commercial Distribution

  • 17290109952724 ()
  • 07290109952871 ()


  • Dermatological laser beam guiding handpiece
POWER BUR KIT
Power Dental U.S.A. Inc.
7806
In Commercial Distribution

  • D9437806 ()
7806

  • Dental spatula, reusable
  • Dental amalgam carrier
  • Fixture/appliance dental drill bit, reusable
TREPHINE BUR SHORT SINK 9mm / 8.2mm X 12.5mm , TOTAL LENGTH 27.5mm
Power Dental U.S.A. Inc.
1931-7
In Commercial Distribution

  • D94319317 ()
1931-7

  • Dental amalgam carrier
  • Dental spatula, reusable
  • Fixture/appliance dental drill bit, reusable
TREPHINE BUR SHORT SINK 8mm / 7.2mm X 12.5mm , TOTAL LENGTH 27.5mm
Power Dental U.S.A. Inc.
1931-6
In Commercial Distribution

  • D94319316 ()
1931-6

  • Dental amalgam carrier
  • Dental spatula, reusable
  • Fixture/appliance dental drill bit, reusable
TREPHINE BUR SHORT SINK 7mm / 6.2mm X 12.5mm , TOTAL LENGTH 27.5mm
Power Dental U.S.A. Inc.
1931-5
In Commercial Distribution

  • D943193150 ()
1931-5

  • Dental spatula, reusable
  • Dental amalgam carrier
  • Fixture/appliance dental drill bit, reusable
TREPHINE BUR SHORT SINK 6mm / 5.2mm X 12.5mm , TOTAL LENGTH 27.5mm
Power Dental U.S.A. Inc.
1931-4
In Commercial Distribution

  • D943193140 ()
1931-4

  • Dental spatula, reusable
  • Dental amalgam carrier
  • Fixture/appliance dental drill bit, reusable
TREPHINE BUR SHORT SINK 5mm / 4.2mm X 12.5mm , TOTAL LENGTH 27.5mm
Power Dental U.S.A. Inc.
1931-3
In Commercial Distribution

  • D94319313 ()
1931-3

  • Dental amalgam carrier
  • Dental spatula, reusable
  • Fixture/appliance dental drill bit, reusable
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