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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 - 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

X SERIES ADVANCED - 00847946049959

DEVICE IDENTIFIER, MAIN ASSY, X SERIES ADVANCED MONITOR/DEFIBRILLATOR, 12 LEAD W/INTERP, PACE, NO VOICE, ETCO2, NIBP, BVM, IBP, NIBP, SPO2, SPCO, SPMET (RAINBOW/MASIMO), CPR EXPANSION PACK, MOBILE STREAMING, GERMAN
Zoll Medical Corporation
630-2241712-08
In Commercial Distribution

  • 00847946049959 ()

  • 8.9" x 10.4" x 8.75"


  • Physiologic-monitoring defibrillation system

“X” Osteotome, 7mm - 00847538006360

“X” Osteotome, 7mm
SYMMETRY MEDICAL INC.
10-008-400
In Commercial Distribution

  • 00847538006360 ()
2709-01-010

  • Orthopaedic osteotome

“X” Osteotome, 7mm - 00847538001235

“X” Osteotome, 7mm
SYMMETRY MEDICAL INC.
10-008-000
In Commercial Distribution

  • 00847538001235 ()
00-9986-010-17;00-9986-010-17

  • Orthopaedic osteotome

MISTER X RAY - D9021050013

No Description
Dental Savings Club Inc
MISTER-X-R#1
In Commercial Distribution

  • D9021050013 ()


  • Dental digital imaging sensor, intraoral

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

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
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