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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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No Description
XIROS LTD
102-1381
In Commercial Distribution

  • 05060267130112 ()
n/a

  • Tendon/ligament bone anchor, non-bioabsorbable
No Description
XIROS LTD
102-1380
In Commercial Distribution

  • 05060267130099 ()
n/a

  • Tendon/ligament bone anchor, non-bioabsorbable
No Description
MANUKAMED LIMITED PARTNERSHIP
MM0121
In Commercial Distribution

  • 05060188824183 ()
  • 05060188824190 ()


  • Exudate-absorbent dressing, non-gel, non-antimicrobial
No Description
MANUKAMED LIMITED PARTNERSHIP
MM0120
In Commercial Distribution

  • 05060188823735 ()
  • 05060188820451 ()


  • Exudate-absorbent dressing, non-gel, non-antimicrobial
Turbines are intended to generate rotating mechanical energy from compressed air
Bien-Air Dental SA
1601086-001
In Commercial Distribution

  • J00716010860011 ()
1601086-001

  • Dental power tool system handpiece, pneumatic
Turbines are intended to generate rotating mechanical energy from compressed air
Bien-Air Dental SA
1601085-001
In Commercial Distribution

  • J00716010850011 ()
1601085-001

  • Dental power tool system handpiece, pneumatic
Q-STAIN X Autostainer
NOVODIAX, INC.
IA01-001
In Commercial Distribution

  • 00850036867159 ()
IA01-001

  • Microscope slide maker/stainer IVD
No Description
HARD MANUFACTURING CO., INC.
1711-BFP
In Commercial Distribution

  • 00852231007552 ()
  • 00852231007545 ()
1711-BFP

  • Paediatric bed
No Description
HARD MANUFACTURING CO., INC.
714-IPGP
In Commercial Distribution

  • 00852231007514 ()
  • 00852231007507 ()
714-IPGP

  • Paediatric bed
Silver-coated antimicrobial barrier dressing
SMITH & NEPHEW MEDICAL LIMITED
20201
In Commercial Distribution

  • 00040565121413 ()
  • 05000223449797 ()
  • 30040565121650 ()
20201

  • Wound-nonadherent dressing, absorbent, antimicrobial
Silicone Gel Sheet. Treatment for red and raised, old and new scars
SMITH & NEPHEW MEDICAL LIMITED
66250706, 66250707
In Commercial Distribution

  • 05000223441814 ()
  • 05000223441579 ()
  • 05000223441821 ()
  • 05000223441654 ()
  • 05000223498351 ()
66250706, 66250707

  • Scar-management dressing, reusable
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, 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 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
SYSMEX CORPORATION
130-4003-0
Not in Commercial Distribution

  • 14987562460257 ()

  • Total Volume: 2 Milliliter


  • Full blood count IVD, control
100 (5 pouches/bag)
BIOMEDICAL LIFE SYSTEMS, INC.
EDRC225250
Not in Commercial Distribution

  • 00857771003804 ()
EDRC225250

  • Transcutaneous electrical stimulation electrode, single-use
20 per pouch
BIOMEDICAL LIFE SYSTEMS, INC.
EDRC225250
Not in Commercial Distribution

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

  • Transcutaneous electrical stimulation electrode, single-use
No Description
Eca Medical Instruments
973-002
In Commercial Distribution

  • 00857676008560 ()
501986

  • Orthopaedic surgical procedure kit, non-medicated, single-use
No Description
Eca Medical Instruments
973-001
In Commercial Distribution

  • 00857676008553 ()
501984

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