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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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ACTICOAT 4" X 4" - 05000223449766

Silver coated anti-mircobial barrier dressing
SMITH & NEPHEW MEDICAL LIMITED
20101
In Commercial Distribution

  • 00040565121352 ()
  • 05000223449766 ()
  • 30040565121643 ()
20101

  • Wound-nonadherent dressing, absorbent, antimicrobial

X SERIES MONITOR/DEFIBRILLATOR - 00847946045470

X SERIES MONITOR/DEFIBRILLATOR, 3/5 LEAD, SPO2, NIBP, TEMP, CPR EXPANSION PACK, ETCO2, DMST
Zoll Medical Corporation
610-0121411-01
In Commercial Distribution

  • 00847946045470 ()


  • Noninvasive device battery charger
  • Internal defibrillation electrode, paediatric
  • Multifunction cardiac electrode, paediatric
  • Blood pressure cuff, single-use
  • External defibrillation electrode, paediatric, reusable
  • Internal defibrillation electrode, adult, reusable
  • Nasal oxygen cannula, carbon-dioxide-sampling
  • External defibrillation electrode, adult, single-use
  • Electrocardiographic electrode, single-use
  • Rechargeable professional automated external defibrillator

RANGE CHECK X lll - 14987562460387

Range Check X lll 24X3.0ML WBC/RBC/PLT
SYSMEX CORPORATION
218981
Not in Commercial Distribution

  • 14987562460387 ()

  • Total Volume: 3 Milliliter


  • Full blood count IVD, control

RANGE CHECK X ll - 14987562460257

Range Check X ll
SYSMEX CORPORATION
130-4003-0
Not in Commercial Distribution

  • 14987562460257 ()

  • Total Volume: 2 Milliliter


  • Full blood count IVD, control

2.25" x 2.50" electrode - 00857771003804

100 (5 pouches/bag)
BIOMEDICAL LIFE SYSTEMS, INC.
EDRC225250
Not in Commercial Distribution

  • 00857771003804 ()
EDRC225250

  • Transcutaneous electrical stimulation electrode, single-use

2.25" x 2.50" electrode - 00857771003309

20 per pouch
BIOMEDICAL LIFE SYSTEMS, INC.
EDRC225250
Not in Commercial Distribution

  • 00857771003309 ()
  • 10857771003306 ()
  • 20857771003303 ()
EDRC225250

  • Transcutaneous electrical stimulation electrode, single-use

iFUSE INTRA X Assist - 00857676008560

No Description
Eca Medical Instruments
973-002
In Commercial Distribution

  • 00857676008560 ()
501986

  • Orthopaedic surgical procedure kit, non-medicated, single-use

iFUSE INTRA X Mallet - 00857676008553

No Description
Eca Medical Instruments
973-001
In Commercial Distribution

  • 00857676008553 ()
501984

  • Orthopaedic surgical procedure kit, non-medicated, single-use

n•x•t Microcuvette - 00657498000236

For the quantitative determination of hemoglobin in capillary, venous or arterial whole blood.
STANBIO LABORATORY, L.P.
3025-050
In Commercial Distribution

  • 00657498000236 ()
  • 00657498001455 ()
3025-050

  • Haemoglobin analyser IVD, point-of-care

PCL-PLUG 2MM X 0.5MM - 00848782024094

Surgical Specialties
Surgical Specialties México, S. de R.L. de C.V.
EPLUG5
In Commercial Distribution

  • 10848782024091 ()
  • 00848782024094 ()

  • Outer Diameter: 0.5 Millimeter


  • Lacrimal punctum plug
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