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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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JOBST Elvarex - 04019702465303

Elvarex 2/Thigh high without foot/Knee Comfort/Thigh high slip form without volant to sew at body bandage/Navy
BSN-Jobst GmbH
79444-00088-00
In Commercial Distribution

  • 04019702465303 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable

JOBST Elvarex - 04019702416275

Elvarex 3/Thigh high without foot/Knee Comfort/Thigh high slip form without volant to sew at body bandage/Cocoa
BSN-Jobst GmbH
79448-00104-00
In Commercial Distribution

  • 04019702416275 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable

JOBST Elvarex - 04019702415988

Elvarex 2/Thigh high without foot/Knee Comfort/Thigh high slip form without volant to sew at body bandage/Cocoa
BSN-Jobst GmbH
79447-00113-00
In Commercial Distribution

  • 04019702415988 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable

JOBST Elvarex - 04019702415254

Elvarex 2/Thigh high without foot/Knee Comfort/Thigh high slip form without volant to sew at body bandage/Cocoa
BSN-Jobst GmbH
79444-00120-00
In Commercial Distribution

  • 04019702415254 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable

JOBST Elvarex - 04019702403237

Elvarex 2/Thigh High/Closed Toe, Knee Comfort/Thigh high slip form without volant to sew at body bandage/Cocoa
BSN-Jobst GmbH
77556-02326-00
In Commercial Distribution

  • 04019702403237 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable

JOBST Elvarex - 04019702345872

Elvarex 3/Leg Extension from below knee to thigh/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
77381-00017-00
In Commercial Distribution

  • 04019702345872 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable

Ambler Surgical - 00190660063528

Maumenee cross-action colibri corneal forceps, 4 3/4'', 0.1mm 1x2 teeth set at 90 degrees, 5.0mm tying platforms, flat handle
AMBLER SURGICAL CORP.
Maumenee cross-action colibri corneal forceps
In Commercial Distribution

  • 00190660063528 ()
2232E

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

Ambler Surgical - 00190660063511

Maumenee cross-action colibri corneal forceps, 4 3/4'', 0.1mm 1x2 teeth set at 45 degrees, 5.0mm tying platforms, flat handle
AMBLER SURGICAL CORP.
Maumenee cross-action colibri corneal forceps
In Commercial Distribution

  • 00190660063511 ()
2231E

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

Ambler Surgical - 00190660005962

Maumenee vitreous aspirating needle, 18 gauge, straight, markings at 10.0mm, 15.0mm and 20.0mm from tip, 25.0mm overall length excluding hub
AMBLER SURGICAL CORP.
Maumenee vitreous aspirating needle
In Commercial Distribution

  • 00190660005962 ()
1066E

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

Ambler Surgical - 00190660005856

Lewicky cortex extractor cannula, 23 gauge, curved, 0.3mm aspiration port set at 45 degrees right, 13.0mm overall length excluding hub
AMBLER SURGICAL CORP.
Lewicky cortex extractor cannula
In Commercial Distribution

  • 00190660005856 ()
1102E

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

Ambler Surgical - 00190660005849

Lewicky cortex extractor cannula, 23 gauge, curved, 0.3mm aspiration port set at 45 degrees left, 13.0mm overall length excluding hub
AMBLER SURGICAL CORP.
Lewicky cortex extractor cannula
In Commercial Distribution

  • 00190660005849 ()
1103E

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

Phaco Choppers - 08175700138727

Chaya Double Ended Chopper, Triple Edged Chopper With Polisher Tip (Verges Style)/Modified Axe Chopper, Offset at 90 Degree, LHD
AURORA SURGICAL, LLC
AS9-052L
In Commercial Distribution

  • 08175700138727 ()
AS9-052L

  • Ophthalmic surgical probe, reusable

Phaco Choppers - 08175700137973

Chaya Double Ended Chopper, Triple Edged Chopper With Polisher Tip (Verges Style)/Modified Axe Chopper, Offset at 90 Degree, RHD
AURORA SURGICAL, LLC
AS9-052R
In Commercial Distribution

  • 08175700137973 ()
AS9-052R

  • Ophthalmic surgical probe, reusable

Kirwan - 00841019122136

Reusable Bipolar Forceps with Tip Angled Down 45 Degrees at 3mm, Insulate to the Angle, and 6" Working Length (Special)
KIRWAN SURGICAL PRODUCTS LLC
12-1436AUS
In Commercial Distribution

  • 00841019122136 ()


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

Novo Surgical - G586OP7127170

o'gawa tying forceps, smooth, 0.5 mm platform, 0.3 mm gap at heel of platform, 4 1/2" (11.0 cm), angled
NOVO SURGICAL, INC.
OP7127-17
In Commercial Distribution

  • G586OP7127170 ()
OP7127-17

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

V. Mueller - 10885403063435

V. Mueller MENISCUS CLAMP CURVED SHANK 1 X 2 TEETH AT TIPS OF JAWS OVERALL LENGTH 7-1/8 inches 18.1CM
STERIS CORPORATION
OS5274
In Commercial Distribution

  • 10885403063435 ()
OS5274

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable

V. Mueller - 10885403033445

V. Mueller JAVID CAROTID ARTERY BYPASS SHUNT CLAMP ANGLED JAWS 6MM AT DISTAL TIP OVERALL LENGTH 7-1/4 inches 18.5CM
STERIS CORPORATION
CH7952
In Commercial Distribution

  • 10885403033445 ()
CH7952

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable

V. Mueller - 10885403033438

V. Mueller JAVID CAROTID ARTERY BYPASS SHUNT CLAMP ANGLED JAWS 4MM AT DISTAL TIP OVERALL LENGTH 6-1/4 inches 15.9CM
STERIS CORPORATION
CH7950
In Commercial Distribution

  • 10885403033438 ()
CH7950

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable

Integra® Miltex® - 10381780417934

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® - 10381780417910

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

Surgical Direct - B382S345563000

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

  • B382S345563000 ()
S34556.300

  • Intraocular retractor, reusable

Titan - 00817914020426

Scoville-Greenwood Bayonet Bipolar Forcep 7 3/4" (196.85mm) Insulated With A With A 0.25mm Tip (*** PRODUCT MAY SCISSOR AT TIPS ***)
TITAN MANUFACTURING INC
162018239010101
In Commercial Distribution

  • 00817914020426 ()

  • Length: 196.85 Millimeter


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

Pointe Scientific - 00811727012425

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

Pointe Scientific, Inc - 00811727012432

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

ISSA 4 - 07350120793010

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 - 07350120793003

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 - 07350120792990

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

PRO-FUSE® - 00884908148923

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

AlcoMate - 00853464001416

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

AlcoMate - 00853464001409

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

AlcoMate - 00853464001393

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

AlcoMate - 00853464001348

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 - 08885014410012

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

STERLINK™ - 08800066500184

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 Sleep Therapy - 00868020000208

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

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® - 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® - 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® - 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® - 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

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® - 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

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® - 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

ever GUIDE KIT - 08806343924049

It is used when removing the gums at the location where the fixture will be installed during dental implant fixture surgery.
Shinhung MST Co., Ltd.
GTP35
In Commercial Distribution

  • 08806343924049 ()


  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable

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

i-ED COIL - 04540778190429

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

i-ED COIL - 04540778190412

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
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