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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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8mm x 23mm Fastlok - 05060267130112

No Description
XIROS LTD
102-1381
In Commercial Distribution

  • 05060267130112 ()
n/a

  • Tendon/ligament bone anchor, non-bioabsorbable

6mm x 23mm Fastlok - 05060267130099

No Description
XIROS LTD
102-1380
In Commercial Distribution

  • 05060267130099 ()
n/a

  • Tendon/ligament bone anchor, non-bioabsorbable

MEDSAF 10 x 12.5cm - 05060188824190

No Description
MANUKAMED LIMITED PARTNERSHIP
MM0121
In Commercial Distribution

  • 05060188824183 ()
  • 05060188824190 ()


  • Exudate-absorbent dressing, non-gel, non-antimicrobial

MEDSAF 5 x 5cm - 05060188823735

No Description
MANUKAMED LIMITED PARTNERSHIP
MM0120
In Commercial Distribution

  • 05060188823735 ()
  • 05060188820451 ()


  • Exudate-absorbent dressing, non-gel, non-antimicrobial

TUR TORNADO X LK - J00716010860011

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

TU Tornado X L - J00716010850011

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 - 00850036867159

Q-STAIN X Autostainer
NOVODIAX, INC.
IA01-001
In Commercial Distribution

  • 00850036867159 ()
IA01-001

  • Microscope slide maker/stainer IVD

24" x 36" Cribette - 00852231007545

No Description
HARD MANUFACTURING CO., INC.
1711-BFP
In Commercial Distribution

  • 00852231007552 ()
  • 00852231007545 ()
1711-BFP

  • Paediatric bed

30" x 44" iCrib - 00852231007507

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

  • 00852231007514 ()
  • 00852231007507 ()
714-IPGP

  • Paediatric bed

ACTICOAT 4" X 8" - 05000223449797

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

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

  • Wound-nonadherent dressing, absorbent, antimicrobial

CICA-CARE 15CM X 12CM - 05000223441579

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

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
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