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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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MSI Precision Specialty Instruments - 00194613085179

Nagahara Ambidextrous Nucleus Chopper, Round Knurled Handle, 1.5mm Tip, Blade Set At 90 Degrees Angle, Overall Length 4 1/2" (11cm)
Med Saver, Inc.
15-3626AS
In Commercial Distribution

  • 00194613085179 ()


  • Ophthalmic knife, reusable

Power Dental USA - D94381007

PIEZO BONE SURGERY TIPS FOR SURGIMASTER AND SURGIMASTER II,DUS5 SHARP AT THREE SIDES HARVESTER TO HARVEST AUTOGENOUS BONE BLOCKS, RIDGE.
Power Dental U.S.A. Inc.
8100-7
In Commercial Distribution

  • D94381007 ()
8100-7

  • Dressing/utility forceps, scissors-like, reusable
  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal

ComPel Isolation Gown - 00634916792713

ComPel Isolation Gown, 3 Armhole, AAMI Level 2, XL, Wrap Around, Velcro at Shoulder, Bound All Around, Long Sleeves with Cuffs
STANDARD TEXTILE CO., INC.
661Y4804
In Commercial Distribution

  • 00634916792713 ()


  • Isolation gown, reusable

AlcoMate - 00853464001119

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

CORTAC® - 00650551087410

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

CORTAC® - 00650551087403

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

CORTAC® - 00650551087335

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

CORTAC® - 00650551087328

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

CORTAC® - 00650551074670

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

Transport shelf - 00670482000722

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

CORTAC® - 00650551062837

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

CORTAC® - 00650551062769

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

CORTAC® - 00650551062752

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

CORTAC® - 00650551050100

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

CORTAC® - 00650551062844

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

PCRopsis - B550227610000

PCRopsis™ BCS Nano (1000 mL) is intended for selective precipitation of red blood cells from whole blood at room temperature.
ENTOPSIS, LLC
BCS Nano
Not in Commercial Distribution

  • B550227610000 ()
22761000

  • Red blood cell separation reagent

PCRopsis - B55022761000

PCRopsis™ BCS Nano (100 mL) is intended for selective precipitation of red blood cells from whole blood at room temperature.
ENTOPSIS, LLC
BCS Nano
Not in Commercial Distribution

  • B55022761000 ()
2276100

  • Red blood cell separation reagent

PCRopsis - B55022760100

PCRopsis™ BCS Nano (10 mL) is intended for selective precipitation of red blood cells from whole blood at room temperature.
ENTOPSIS, LLC
BCS Nano
Not in Commercial Distribution

  • B55022760100 ()
2276010

  • Red blood cell separation reagent

Titan - 00817914021287

M-Style Straight Bipolar Forcep 6 3/4" (171.45mm) With A With A 0.2mm Tip With Stop (*** PRODUCT MAY SCISSOR AT TIPS ***)
TITAN MANUFACTURING INC
163210131000101
In Commercial Distribution

  • 00817914021287 ()

  • Length: 171.45 Millimeter


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Integra Peritoneal Open-Ended Catheter With Slits - 10381780072546

Integra Peritoneal Open-Ended Catheter With Slits PERITONEAL CATHETER, 90CM LENGTH 12 mm H2O at a flow rate of 23 ml/hr.
Integra Lifesciences Corporation
NL98003S01
In Commercial Distribution

  • 10381780072546 ()
  • M269NL98003S011 ()

  • Tubing: 1.3mm ID x 2.5mm OD; Total Length: 90 cm (35 1/2") (All dimensions nominal)
NL98003S01

  • Peritoneal/atrial cerebrospinal fluid catheter

Surgical Direct - B382S34556300T0

Pre-op Toric Reference Marker, Titanium, Half Circle With 3 Points At 0, 90 and 180 Degrees On A Round Knurled Handle
Surgical Direct, Inc.
S34556.300T
In Commercial Distribution

  • B382S34556300T0 ()
S34556.300T

  • Intraocular retractor, reusable

Surgical Direct - B382S28530000

3 1/2" Utrata Forceps, Short 3-Hole Handle, Laser Lines at 2.5mm and 5.0mm, 12mm Bend to Tip, Delicate Triangular Tips
Surgical Direct, Inc.
S2853.000
In Commercial Distribution

  • B382S28530000 ()
S2853.000

  • Dressing/utility forceps, scissors-like, reusable

Vitreoretinal Viscodissector 45-Degree - 00813465011708

Dissection of vitreoretinal membranes using viscoelastic fluid. 30 gauge tip, 5mm long and angled at 45 degrees. Extension tube length 20cm.
HURRICANE MEDICAL INC
7519
In Commercial Distribution

  • 10813465011705 ()
  • 00813465011708 ()

  • Length: 33 Millimeter
  • Needle Gauge: 20 Gauge
7519

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Vitreoretinal Viscodissector 70-Degree - 00813465011692

Dissection of vitreoretinal membranes using viscoelastic fluid. 30 gauge tip, 5mm long and angled at 70 degrees. Extension tube length 20cm.
HURRICANE MEDICAL INC
7518
In Commercial Distribution

  • 10813465011699 ()
  • 00813465011692 ()

  • Length: 33 Millimeter
  • Needle Gauge: 20 Gauge
7518

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Vitreoretinal Viscodissector 90-Degree - 00813465011685

Dissection of vitreoretinal membranes using viscoelastic fluid. 30 gauge tip, 5mm long and angled at 90 degrees. Extension tube length 20cm.
HURRICANE MEDICAL INC
7517
In Commercial Distribution

  • 10813465011682 ()
  • 00813465011685 ()

  • Length: 33 Millimeter
  • Needle Gauge: 20 Gauge
7517

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Neotech Bridge® - 00812594013478

The Neotech Bridge is a breastfeeding assistance device intended to deliver supplemental nutrition to an infant latched at the breast/chest.
Neotech Products LLC
Kit – Bridge with Extension and 20ML & 60ML Syringes
In Commercial Distribution

  • 00812594013478 ()
N8001-Kit

  • Breast pump support kit, reusable

Oxygen Demand Valve - 07540195020122

The Oxygen Demand Valve provides 100% oxygen to patients suffering from respiratory distress at the flow rate demanded by the patient.
O-Two Medical Technologies Inc
01DV3000
In Commercial Distribution

  • 07540195020115 ()
  • 07540195020122 ()

  • Weight: 0.20 Kilogram
  • Height: 3.1 Inch
  • Outer Diameter: 2.0 Inch
01DV3000

  • Demand valve

Hayden Medical - 00840319707715

St. Mark's Deep Pelvic Fiber-Optic Retractor, hollow handle, 7" narrow version tapers to 3-1/2cm's at tip with lip (universal connection)
Hayden Medical, Inc.
240-585L
In Commercial Distribution

  • 00840319707715 ()
240-585L

  • Hand-held surgical retractor, reusable

Resp-O2 Heat Moisture Exchanger (HME) 1500 With Integrated Flex Tube - 00840117318090

Tidal Volume Range(250-1500mL), Media(Foam), Dead Space(90mL), Breathing Resistance (1.6cm H2O at 60 L/min), Weight(15.5g). Adult/Pediatric
Dynarex Corporation
30202
In Commercial Distribution

  • 00840117318083 ()
  • 00840117318090 ()


  • Heat/moisture exchanger, single-use

Resp-O2 Heat Moisture Exchanger (HME) Tracheostomy with Side Oxygen Port - 00840117305885

Adult/Ped: Tidal Volume Range(300-1500mL), Breathing Resistance(1.8cm H2O at 60L/min, Media(Corrugated Paper), Dead Space(15mL), Weight(8.4g)
Dynarex Corporation
30309
In Commercial Distribution

  • 00840117305892 ()
  • 00840117305885 ()


  • Heat/moisture exchanger, single-use
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