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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Nova Nitrile Powder-Free, X-Small, Super-stretchy nitrile, Textured fingertips, Very durable, Violet-blue in color, Packaging contains at least 70% recycled material
PURELIFE, LLC
1060101
In Commercial Distribution

  • D79010601013 ()
  • D79010601011 ()
  • D79010601010 ()
1060101

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Integra® Miltex® Sims Rectal Speculum, 6", Fenestrated Blades, 3-1/2" Deep x 5/8" Wide At Distal End
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
MH28-2
In Commercial Distribution

  • H834MH2820 ()
  • 10381780488088 ()
MH28-2

  • Rectal speculum
Integra® Miltex® Iris Tissue Forceps 3-7/8", Standard, Full Curved, 1 x 2 Teeth, 0.8mm wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-790
In Commercial Distribution

  • H834187900 ()
  • 10381780417934 ()
18-790

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Integra® Miltex® Iris Tissue Forceps 3-7/8", Standard, Half Curved, 1 x 2 Teeth, 0.8mm wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-788
In Commercial Distribution

  • H834187880 ()
  • 10381780417910 ()
18-788

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
ISE Standard - High For the standardization of Sodium, Potassium and Chloride on Ion Selective Electrodes. packaged at 10 x 2ml
POINTE SCIENTIFIC, INC.
HI790-STH
In Commercial Distribution

  • 00811727012432 ()
HI790-STH

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
ISE Standard - Low For the standardization of Sodium, Potassium and Chloride on Ion Selective Electrodes. packaged at 10 x 2ml
POINTE SCIENTIFIC, INC.
HI790-STL
In Commercial Distribution

  • 00811727012425 ()
HI790-STL

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
9.6F PLASTIC Pro-Fuse® CT PORT W/ATTACHABLECT PORT W/AT SILICONE CATHETER W/5FSILICONE C Micro-Stick®INTRODUCER SE
Medical Components, Inc.
MIPP96AFS
Not in Commercial Distribution

  • 50884908148928 ()
  • 00884908148923 ()
MIPP96AFS

  • Vascular port/catheter
ISSA 4 is for use at home and to promote overall oral hygiene by cleaning your teeth and gums only.
Foreo AB
Arctic Blue
In Commercial Distribution

  • 07350120793010 ()


  • Basic electric toothbrush
ISSA 4 is for use at home and to promote overall oral hygiene by cleaning your teeth and gums only.
Foreo AB
Pearl Pink
In Commercial Distribution

  • 07350120793003 ()


  • Basic electric toothbrush
ISSA 4 is for use at home and to promote overall oral hygiene by cleaning your teeth and gums only.
Foreo AB
Fuchsia
In Commercial Distribution

  • 07350120792990 ()


  • Basic electric toothbrush
House Crabtree Dissector Pick, 1.5mm Flattened Tip Angled At 90 Degrees, Straight Shaft, Round Handle, Overall Length 6-1/2" (167mm)
Med Saver, Inc.
114-2816-83J
In Commercial Distribution

  • 00194613085322 ()


  • Open-surgery dissector
Nagahara Ambidextrous Nucleus Chopper, 1.5mm Tip, Blade Set At 90 Degrees Angle, Round Knurled Handle, Overall Length 4-1/2" (110mm)
Med Saver, Inc.
15-3626AS
In Commercial Distribution

  • 00194613085179 ()


  • Ophthalmic knife, reusable
O'Gawa Tying Forceps, Curved, 5.5mm Tying Platform, 0.3mm Gap At Platform Heel, Round Knurled Handle, Overall Length 4-1/8" (105mm)
Med Saver, Inc.
5-2992
In Commercial Distribution

  • 00194613108892 ()


  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Day Ear Hook, Medium, 2mm Blunt Tip, Angled At 90 Degrees, Small Round Knurled Handle, Overall Length 6-1/3" (159mm)
Med Saver, Inc.
114-1581-2
In Commercial Distribution

  • 00194613105860 ()


  • Soft-tissue surgical hook, reusable
House Crabtree Dissector Pick, 1.5mm Flattened Tip Angled At 90 Degrees, Straight Shaft, Round Handle, Overall Length 6-1/2" (167mm)
Med Saver, Inc.
114-2816-83JS
In Commercial Distribution

  • 00194613022136 ()


  • Open-surgery dissector
Fuel-Cell technology provides you with increased precision and accuracy, and also less worry with maintenance, since fuel-cell alcohol sensor modules are rated to at least 1000 tests before needing replacement. Fuel-Cell Sensor Modules should be replaced approximately every 1000 tests, or at least once yearly.
AK Globaltech Corp
SM3500FC
In Commercial Distribution

  • 00853464001416 ()
AKG-SM3500FC

  • Alcohol breath analyser
Fuel-Cell technology provides you with increased precision and accuracy, and also less worry with maintenance, since fuel-cell alcohol sensor modules are rated to at least 1000 tests before needing replacement. Fuel-Cell Sensor Modules should be replaced approximately every 1000 tests, or at least once yearly.
AK Globaltech Corp
SM3100
In Commercial Distribution

  • 00853464001409 ()
AKG-SM3100

  • Alcohol breath analyser
Fuel-Cell technology provides you with increased precision and accuracy, and also less worry with maintenance, since fuel-cell alcohol sensor modules are rated to at least 1000 tests before needing replacement. Fuel-Cell Sensor Modules should be replaced approximately every 1000 tests, or at least once yearly.
AK Globaltech Corp
SM600
In Commercial Distribution

  • 00853464001393 ()
AKG-SM600

  • Alcohol breath analyser
Fuel-Cell technology provides you with increased precision and accuracy, and also less worry with maintenance, since fuel-cell alcohol sensor modules are rated to at least 1000 tests before needing replacement. Fuel-Cell Sensor Modules should be replaced approximately every 1000 tests, or at least once yearly.
AK Globaltech Corp
SM200
In Commercial Distribution

  • 00853464001348 ()
AKG-SM200

  • Alcohol breath analyser
BPro® Ambulatory Blood Pressure Monitoring System is a noninvasive ambulatory blood pressure monitoring (ABPM) system based on arterial tonometry at the radial artery and oscillometry at the upper arm. It is used for measuring systolic pressure, diastolic pressure and pulse rate of adults.
HEALTHSTATS INTERNATIONAL PTE LTD
T6200 Series
Not in Commercial Distribution

  • 08885014410012 ()


  • Blood pressure ambulatory recorder
Terragene Bionova® SCBI(BT96) is a self-contained biological indicator inoculated with viable 10^6 Geobacillus sterotheromophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydorgen peroxide sterilization processes. BT96 has Super Rapid readout at 30 minutes at 60 degree celsius.
Plasmapp Co.,Ltd.
BT96
In Commercial Distribution

  • 08800066500184 ()


  • Biological sterilization indicator
Provent 30 Night Standard Pack contains 30 Standard resistance Provent
PROVENT SLEEP THERAPY, LLC
CAT1105
In Commercial Distribution

  • 00868020000208 ()

  • Expiratory Resistance 3.0 >= x < 8.0 cm H2O at 50 mL/sec flow rate per nostril
CAT1105

  • Nasal dilator
SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 2X8, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111TX-16-066-NS
In Commercial Distribution

  • 00650551087410 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111TX-16-066-NS

  • Cortical electrode
SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 2X8, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111-16-066-NS
In Commercial Distribution

  • 00650551087403 ()

  • Thickness 0.5 Millimeter
  • Contact Diameter 3 Millimeter
2111-16-066-NS

  • Cortical electrode
SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 4X4, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111TX-16-062-NS
In Commercial Distribution

  • 00650551087335 ()

  • Thickness 0.5 Millimeter
  • Contact Diameter 3 Millimeter
2111TX-16-062-NS

  • Cortical electrode
SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 4X4, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111-16-062-NS
In Commercial Distribution

  • 00650551087328 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111-16-062-NS

  • Cortical electrode
SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 2X8, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111TX-16-066
In Commercial Distribution

  • 00650551062844 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111TX-16-066

  • Cortical electrode
SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 2X8, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111-16-066
In Commercial Distribution

  • 00650551062837 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111-16-066

  • Cortical electrode
SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 4X4, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111TX-16-062
In Commercial Distribution

  • 00650551062769 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111TX-16-062

  • Cortical electrode
SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 4X4, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111-16-062
In Commercial Distribution

  • 00650551062752 ()

  • Thickness 0.5 Millimeter
  • Contact Diameter 3 Millimeter
2111-16-062

  • Cortical electrode
SUBDURAL STRIP ELECTRODE, PLATINUM, 8 CONTACT, 1X8, RADIOPAQUE "L" AT CONTACT #1 & #8, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2110-08-093-NS
In Commercial Distribution

  • 00650551074670 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.76 Millimeter
2110-08-093-NS

  • Cortical electrode
The 2nd Generation Re-Inforced Semiconductor Sensor by AlcoMate. Replacement needed every 200 tests or at least once yearly, whichever comes first.
AK Globaltech Corp
SM7000
In Commercial Distribution

  • 00853464001119 ()
AKG SM7000

  • Alcohol breath analyser
The transport shelf is an accessory. It's intended to be installed at foot end of the bed in the corner bumper.
Umano Medical Inc
299-0523WG-TRI
In Commercial Distribution

  • 00670482000722 ()
  • 10670482000729 ()


  • Basic electric hospital bed
SUBDURAL STRIP ELECTRODE, PLATINUM, 8 CONTACT, 1X8, RADIOPAQUE "L" AT CONTACT #1 & #8, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2110-08-093
In Commercial Distribution

  • 00650551050100 ()

  • Thickness 0.76 Millimeter
  • Contact Diameter 3 Millimeter
2110-08-093

  • Cortical electrode
A device used for controlling connected electrical devices that are programmed to function/operate at or between set intervals of time.
Pride Mobility Products Corp
TIMER SWITCH
In Commercial Distribution

  • 00606509900133 ()
N/A

  • Timer switch
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
393-030530
In Commercial Distribution

  • 04540778190429 ()

  • Complex (Infini Silky Soft) 12inch 3-5mm x 30cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
393-030530

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
390-0212
In Commercial Distribution

  • 04540778190412 ()

  • Complex (Silky Soft) 10inch 2mm x 12cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
390-0212

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
374-142450
In Commercial Distribution

  • 04540778177796 ()

  • Helical (Infini Standard) 17inch 14-24mm x 50cm
  • Compatible Microcatheter inner diameter: 0.48 to 0.53 Millimeter
374-142450

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
373-122050
In Commercial Distribution

  • 04540778177772 ()

  • Helical (Infini Standard) 14inch 12-20mm x 50cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
373-122050

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
373-051250
In Commercial Distribution

  • 04540778177734 ()

  • Helical (Infini Soft) 14inch 5-12mm x 50cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
373-051250

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
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