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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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Dermagold100 - 04260484571823

The OW100S is indicated to provide acoustic pressure shockwave in the treatment of chronic, full-thickness diabetic foot ulcer with wound area measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The OW100S is indicated for adult (22 year and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care. The OW100S is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 year or older). The OW100S is indicated for use in conjunction with standard of care burn treatment(s).
MTS Medical AG
OW100S-US
In Commercial Distribution

  • 04260484571830 ()
  • 04260484571823 ()

  • Weight: 21 Kilogram
  • Depth: 459 Millimeter
  • Width: 400 Millimeter
  • Height: 218 Millimeter
1000022

  • Dermatological extracorporeal shock wave therapy system

VIASURE - 04260484571687

Indications for Use The VIASURE is intended for : • Relief of minor muscle aches and pains • Temporary increase in local blood circulation • Activation of connective tissue
MTS Medical AG
OW100-US
In Commercial Distribution

  • 04260484571694 ()
  • 04260484571687 ()

  • Weight: 18 Kilogram
  • Depth: 459 Millimeter
  • Width: 400 Millimeter
  • Height: 218 Millimeter
1000015

  • Freestanding electric massager

DermaGold100® - 04260484571649

The DermaGold100® is intended for treatment of - diabetic footulcers - superficial partial thickness second degree burns in adults (22 years and older). The dermagold100 is indicated for use in conjunction with standard of care burn treatment(s)
MTS Medical AG
OW100-US
In Commercial Distribution

  • 04260484571649 ()
  • 04260484571656 ()

  • Weight: 18 Kilogram
  • Depth: 459 Millimeter
  • Width: 400 Millimeter
  • Height: 218 Millimeter
1000014

  • Dermatological extracorporeal shock wave therapy system

OrthoGold100® - 04260484571601

Indications for Use The OrthoGold100® is intended for : • Relief of minor muscle aches and pains • Temporary increase in local blood circulation • Activation of connective tissue
MTS Medical AG
OW100-US
In Commercial Distribution

  • 04260484571618 ()
  • 04260484571601 ()

  • Weight: 18 Kilogram
  • Depth: 459 Millimeter
  • Width: 400 Millimeter
  • Height: 218 Millimeter
1000013

  • Freestanding electric massager

Softwave Gold Li - 04260484571267

The OW100S-US is indicated to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. OW100S-US is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care. The OW100S-US is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 years or older). The OW100S-US is indicated for use in conjunction with standard of care burn treatment(s)
MTS Medical AG
OW100S-US
In Commercial Distribution

  • 04260484571274 ()
  • 04260484571267 ()

  • Weight: 21 Kilogram
  • Depth: 459 Millimeter
  • Width: 400 Millimeter
  • Height: 218 Millimeter
1000024

  • Dermatological extracorporeal shock wave therapy system

ALTMS Magnetic Stimulation Therapy System (Blossom TMS Therapy System) - 08809308380546

ALTMS Magnetic Stimulation Therapy System (Blossom TMS Therapy System)_SW Protocol Change ver
REMED Co.,Ltd.
C-01
In Commercial Distribution

  • 08809308380546 ()


  • Magnetic neural stimulation system

ALTMS Magnetic Stimulation Therapy System (Blossom TMS Therapy System) - 08809308380539

ALTMS Magnetic Stimulation Therapy System (Blossom TMS Therapy System)_18.8min ver
REMED Co.,Ltd.
B-01
In Commercial Distribution

  • 08809308380539 ()


  • Magnetic neural stimulation system

ALTMS Magnetic Stimulation Therapy System - 08809308380522

ALTMS Magnetic Stimulation Therapy System_Traditional ver
REMED Co.,Ltd.
A-01
In Commercial Distribution

  • 08809308380522 ()


  • Magnetic neural stimulation system

Spectra - 08809108017710

The Spectra Wearable is powered breast pumps intended for use of lactating women to stimulate, express and collect milk from user’s breast. The final product is packed in a box with neccessary parts including breast shied, silicone valve, silicone membrane, bottle, bottle connector, connector pin, airtight cap, pp bottle, nipple, screw cap, cover, power adapter and instruction for use.
UZINMEDICARE CO.,LTD
Spectra Wearable
In Commercial Distribution

  • 28809108017714 ()
  • 08809108017710 ()
MM011500

  • Breast pump, electric

Spectra - 08809108017697

The Spectra Wearable is powered breast pumps intended for use of lactating women to stimulate, express and collect milk from user’s breast. The final product is packed in a box with neccessary connecting parts including breast shied, silicone valve, silicone membrane, bottle connector, handsfree bottle, airtight cap, power adaptor and instruction for use. so, the user can use the device right after receving them.
UZINMEDICARE CO.,LTD
Spectra Wearable
In Commercial Distribution

  • 28809108017691 ()
  • 08809108017697 ()


  • Breast pump, electric
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