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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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Solitaire™ X - 00847536034730

STENT SFR4-6-40-10 V01 US
Micro Therapeutics, Inc.
SFR4-6-40-10
In Commercial Distribution

  • 00847536034730 ()


  • Thrombectomy wire-net

Solitaire™ X - 00847536034723

STENT SFR4-6-24-06 V01 US
Micro Therapeutics, Inc.
SFR4-6-24-06
In Commercial Distribution

  • 00847536034723 ()


  • Thrombectomy wire-net

Solitaire™ X - 00847536034716

STENT SFR4-6-20-10 V01 US
Micro Therapeutics, Inc.
SFR4-6-20-10
In Commercial Distribution

  • 00847536034716 ()


  • Thrombectomy wire-net

Solitaire™ X - 00847536034709

STENT SFR4-4-40-10 V01 US
Micro Therapeutics, Inc.
SFR4-4-40-10
In Commercial Distribution

  • 00847536034709 ()


  • Thrombectomy wire-net

Solitaire™ X - 00847536034693

STENT SFR4-4-20-10 V01 US
Micro Therapeutics, Inc.
SFR4-4-20-10
In Commercial Distribution

  • 00847536034693 ()


  • Thrombectomy wire-net

Solitaire™ X - 00847536034686

STENT SFR4-4-20-05 V01 US
Micro Therapeutics, Inc.
SFR4-4-20-05
In Commercial Distribution

  • 00847536034686 ()


  • Thrombectomy wire-net

Perfectio X G2 - 00850001456548

Over the counter red/IR device for the treatment of wrinkles.
Omm Imports Inc.
G2-PX
In Commercial Distribution

  • 00850001456548 ()


  • Cosmetic red-light phototherapy system, home-use

ValuTrode X Foam - 00856817005291

No Description
AXELGAARD MANUFACTURING CO., LTD.
VTX2020
In Commercial Distribution

  • 00856817005291 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Transcutaneous electrical stimulation electrode, reusable

ValuTrode X Foam - 00856817005284

No Description
AXELGAARD MANUFACTURING CO., LTD.
VTX2000
In Commercial Distribution

  • 00856817005284 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Transcutaneous electrical stimulation electrode, reusable

ValuTrode X Cloth - 00856817005277

No Description
AXELGAARD MANUFACTURING CO., LTD.
VTX5050
In Commercial Distribution

  • 00856817005277 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Transcutaneous electrical stimulation electrode, reusable

ValuTrode X Cloth - 00856817005260

No Description
AXELGAARD MANUFACTURING CO., LTD.
VTX5000
In Commercial Distribution

  • 00856817005260 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Transcutaneous electrical stimulation electrode, reusable

DermLite Foto X - 00855997006630

Dermoscopy lens for camera devices (polarized, non-polarized, rechargeable, adjustable faceplate spacer)
DermLite LLC
DLFX
In Commercial Distribution

  • 00855997006630 ()
DLFX

  • Dermatoscope, optical

UltraStim X Derma - 00851913006395

No Description
AXELGAARD MANUFACTURING CO., LTD.
USXD2040
Not in Commercial Distribution

  • 00851913006395 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Transcutaneous electrical stimulation electrode, reusable

UltraStim X Derma - 00851913006388

No Description
AXELGAARD MANUFACTURING CO., LTD.
USXD2020
Not in Commercial Distribution

  • 00851913006388 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Transcutaneous electrical stimulation electrode, reusable

UltraStim X Blue - 00851913006326

No Description
AXELGAARD MANUFACTURING CO., LTD.
USXB50100
In Commercial Distribution

  • 00851913006326 ()


  • Transcutaneous electrical stimulation electrode, reusable
  • Transcutaneous electrical stimulation electrode, single-use

UltraStim X Blue - 00851913006319

No Description
AXELGAARD MANUFACTURING CO., LTD.
USXB5050
In Commercial Distribution

  • 00851913006319 ()


  • Transcutaneous electrical stimulation electrode, reusable
  • Transcutaneous electrical stimulation electrode, single-use

UltraStim X Blue - 00851913006234

No Description
AXELGAARD MANUFACTURING CO., LTD.
USXPB5000
Not in Commercial Distribution

  • 00851913006234 ()


  • Transcutaneous electrical stimulation electrode, single-use

UltraStim X Foam - 00851913006173

No Description
AXELGAARD MANUFACTURING CO., LTD.
USXF204
In Commercial Distribution

  • 00851913006173 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Transcutaneous electrical stimulation electrode, reusable

UltraStim X Foam - 00851913006166

No Description
AXELGAARD MANUFACTURING CO., LTD.
USXF202
In Commercial Distribution

  • 00851913006166 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Transcutaneous electrical stimulation electrode, reusable

UltraStim X Foam - 00851913006159

No Description
AXELGAARD MANUFACTURING CO., LTD.
USXF200
In Commercial Distribution

  • 00851913006159 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Transcutaneous electrical stimulation electrode, reusable
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