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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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RESORB X - 00888118096975

XCELSIOR WATER BATH, WATER CONTAINER
KLS-Martin L.P.
52-400-14-04
In Commercial Distribution

  • 00888118096975 ()


  • Surgical water bath system

RESORB X - 00888118096937

TAP, POSITIVE STOP, HEX, 2.1 MM, 11.5 MM STOP, DRILL FREE, FOR BOS
KLS-Martin L.P.
52-019-20-07
In Commercial Distribution

  • 00888118096937 ()

  • 70 MM


  • Bone tap, single-use

STOP X - 07290018007686

STOP X MODEL STOP U PACKED GRADIENT RED USA
POLLOGEN LTD
STOP U
In Commercial Distribution

  • 07290018007686 ()
34300010GR-US

  • Multi-modality skin/body contouring system

STOP X - 07290018007303

STOP X MODEL STOP U PACKED R.G-CHRM USA
POLLOGEN LTD
Model U
In Commercial Distribution

  • 07290018007303 ()
34300010RP-US

  • Multi-modality skin/body contouring system

Lightning X - 06946430421586

Single patient use manual resuscitator for use in hospital,transport,emergency,and post hospital care to temporary ventilate a patient for the given body mass ranges of: Infant: less than or equal to 10Kg, Child: less than or equal to 23 Kg, Adult: greater than 23 Kg.
XIAMEN COMPOWER MEDICAL TECH. CO., LTD
NPVC-003/RTMA1
In Commercial Distribution

  • 16946430421583 ()
  • 06946430421586 ()


  • Pulmonary resuscitator, manual, single-use

Lightning X - 06946430421579

Single patient use manual resuscitator for use in hospital,transport,emergency,and post hospital care to temporary ventilate a patient for the given body mass ranges of: Infant: less than or equal to 10Kg, Child: less than or equal to 23 Kg, Adult: greater than 23 Kg.
XIAMEN COMPOWER MEDICAL TECH. CO., LTD
NPVC-002/RTMA
In Commercial Distribution

  • 06946430421579 ()
  • 16946430421576 ()


  • Pulmonary resuscitator, manual, single-use

X- WASH - 00886368000797

X- WASH DOCKING STATION
Thermogenesis Corp.
80070
In Commercial Distribution

  • 00886368000797 ()
  • 00886368000780 ()


  • Blood centrifugation system containment kit

X- Mixer - 00886368000025

X-Mixer
Thermogenesis Corp.
80095
In Commercial Distribution

  • 00886368000025 ()
  • 00886368000018 ()


  • Blood centrifugation system containment kit

X SERIES - 00812394026937

X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, NIBP, SPO2, CPR EXPANSION PACK, BRAZILIAN PORTUGUESE, REFURB
Zoll Medical Corporation
602-2220011-24-66
In Commercial Distribution

  • 00812394026937 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026913

X SERIES MONITOR/DEFIBRILLATOR W/PACING, 12 LEAD W/INTERP, SPO2, NIBP, IBP/TEMP, CPR EXPANSION PACK, ETCO2, BRAZILIAN PORTUGUESE, REFURB
Zoll Medical Corporation
602-2221511-24-66
In Commercial Distribution

  • 00812394026913 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026890

X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, SPO2, ETCO2, NIBP, CPR EXPANSION PACK, BRAZILIAN PORTUGUESE, REFURB
Zoll Medical Corporation
602-2221011-24-66
In Commercial Distribution

  • 00812394026890 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026883

MAIN ASSY, X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, NIBP, SPO2, CPR EXPANSION PACK, SO. AMERICAN SPANISH, REFURB
Zoll Medical Corporation
620-2220011-23-66
In Commercial Distribution

  • 00812394026883 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026852

X SERIES MONITOR/DEFIBRILLATOR W/PACING, 12 LEAD W/INTERP, SPO2, NIBP, IBP/TEMP, CPR EXPANSION PACK, ETCO2, SO. AMERICAN SPANISH, 60HZ, REFURB
Zoll Medical Corporation
602-2221511-23-66
In Commercial Distribution

  • 00812394026852 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026364

X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 3/5 LEAD, SPO2, BVM, NIBP, CPR EXPANSION PACK, CANADIAN, REFURB, (TIER 2)
Zoll Medical Corporation
601-0120111-06-662
In Commercial Distribution

  • 00812394026364 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026319

X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12 LEAD W/INTERP, PACE, ETCO2, NIBP, SPO2/SPCO, BVM/TEMP, CPR EXPANSION PACK, US, REFURB (TIER 1)
Zoll Medical Corporation
601-2231211-01-661
In Commercial Distribution

  • 00812394026319 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026296

X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12 LEAD W/INTERP, PACE, ETCO2, NIBP, SPO2/SPCO, BVM, CPR EXPANSION PACK, US, REFURB (TIER 2)
Zoll Medical Corporation
601-2231111-01-662
In Commercial Distribution

  • 00812394026296 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026265

DEVICE IDENTIFIER, X SERIES MONITOR/DEFIBRILLATOR W/PACING, 12 LEAD W/INTERP, SPO2, NIBP, IBP/TEMP, CPR EXPANSION PACK, ETCO2, DMST, REFURB (TIER 4, CONTAINS 610)
Zoll Medical Corporation
601-2221511-01-664
In Commercial Distribution

  • 00812394026265 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026241

X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, NIBP, SPO2, CPR EXPANSION PACK, ETCO2, DMST, REFURB (TIER 4, CONTAINS 610)
Zoll Medical Corporation
601-2221011-01-664
In Commercial Distribution

  • 00812394026241 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026197

X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, SPCO, IBP/TEMP CPR EXPANSION PACK AND ETCO2, DMST, REFURB, (TIER 3)
Zoll Medical Corporation
601-2231511-01-663
In Commercial Distribution

  • 00812394026197 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026173

X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, SPCO, IBP/TEMP CPR EXPANSION PACK AND ETCO2, DMST, REFURB (TIER 1)
Zoll Medical Corporation
601-2231511-01-661
In Commercial Distribution

  • 00812394026173 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026166

X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, NIBP, SPO2, SPCO, CPR EXPANSION PACK, ETCO2, DMST, REFURB (TIER 3)
Zoll Medical Corporation
601-2231011-01-663
In Commercial Distribution

  • 00812394026166 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026142

X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, NIBP, SPO2, SPCO, CPR EXPANSION PACK, ETCO2, DMST, REFURB (TIER 1)
Zoll Medical Corporation
601-2231011-01-661
In Commercial Distribution

  • 00812394026142 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026128

X SERIES MONITOR/DEFIBRILLATOR W/PACING, 12 LEAD W/INTERP, SPO2, NIBP, IBP/TEMP, CPR EXPANSION PACK, ETCO2, DMST, REFURB (TIER 2)
Zoll Medical Corporation
601-2221511-01-662
In Commercial Distribution

  • 00812394026128 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026104

X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, NIBP, SPO2, CPR EXPANSION PACK, ETCO2, DMST, REFURB (TIER 3)
Zoll Medical Corporation
601-2221011-01-663
In Commercial Distribution

  • 00812394026104 ()


  • Rechargeable professional automated external defibrillator

X FIX - 00887868083624

No Description
Biomet Orthopedics, LLC
06258
In Commercial Distribution

  • 00887868083624 ()
06258

  • External orthopaedic fixation system, single-use

X FIX - 00887868083556

No Description
Biomet Orthopedics, LLC
06187
In Commercial Distribution

  • 00887868083556 ()

  • 15MM SPACER TEMPLATE
06187

  • Surgical implant template, reusable

X FIX - 00887868083532

No Description
Biomet Orthopedics, LLC
06182
In Commercial Distribution

  • 00887868083532 ()

  • 12MM SPACER TEMPLATE
06182

  • Surgical implant template, reusable

X FIX - 00887868083518

No Description
Biomet Orthopedics, LLC
06177
In Commercial Distribution

  • 00887868083518 ()

  • 9MM SPACER TEMPLATE
06177

  • Surgical implant template, reusable

X FIX - 00887868083303

No Description
Biomet Orthopedics, LLC
05080
In Commercial Distribution

  • 00887868083303 ()
05080

  • Surgical torque wrench, reusable

X FIX - 00887868083266

No Description
Biomet Orthopedics, LLC
05040
In Commercial Distribution

  • 00887868083266 ()
05040

  • Surgical torque wrench, reusable

X FIX - 00887868083235

No Description
Biomet Orthopedics, LLC
05025
In Commercial Distribution

  • 00887868083235 ()
05025

  • Surgical drill guide, reusable

X FIX - 00887868083228

No Description
Biomet Orthopedics, LLC
05021
In Commercial Distribution

  • 00887868083228 ()
05021

  • Surgical drill guide, reusable

X FIX - 00887868083211

No Description
Biomet Orthopedics, LLC
05020
In Commercial Distribution

  • 00887868083211 ()
05020

  • Surgical drill guide, reusable

X FIX - 00887868081880

No Description
Biomet Orthopedics, LLC
03155
In Commercial Distribution

  • 00887868081880 ()
03155

  • Instrument tray, reusable

X FIX - 00887868081859

No Description
Biomet Orthopedics, LLC
03111
In Commercial Distribution

  • 00887868081859 ()
03111

  • Surgical torque wrench, reusable

X FIX - 00887868081828

No Description
Biomet Orthopedics, LLC
03100
In Commercial Distribution

  • 00887868081828 ()
03100

  • Surgical depth gauge, reusable

X FIX - 00887868081811

No Description
Biomet Orthopedics, LLC
03095
In Commercial Distribution

  • 00887868081811 ()
03095

  • Surgical drill guide, reusable

X FIX - 00887868081804

No Description
Biomet Orthopedics, LLC
03090
In Commercial Distribution

  • 00887868081804 ()
03090

  • Orthopaedic implantation sleeve, reusable

X FIX - 00887868081798

No Description
Biomet Orthopedics, LLC
03085
In Commercial Distribution

  • 00887868081798 ()
03085

  • Orthopaedic implantation sleeve, reusable

X FIX - 00887868081781

No Description
Biomet Orthopedics, LLC
03080
In Commercial Distribution

  • 00887868081781 ()
03080

  • Orthopaedic implantation sleeve, reusable
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