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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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Novo Surgical - 00842331117848

Hendren Clamp, very delicate cooley teeth, jaws calibrated at 5.0 mm intervals, 8-1/4" (21.0 cm), jaw base 18.0 mm
NOVO SURGICAL, INC.
5565-44
Not in Commercial Distribution

  • 00842331117848 ()

  • Length: 21 Centimeter
5565-44

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

Novo Surgical - 00842331117831

Hendren Clamp, very delicate cooley teeth, jaws calibrated at 5.0 mm intervals, 8-1/4" (21.0 cm), jaw base 12.0 mm
NOVO SURGICAL, INC.
5565-42
Not in Commercial Distribution

  • 00842331117831 ()

  • Length: 21 Centimeter
5565-42

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

Novo Surgical - 00842331117824

Hendren Clamp, very delicate cooley teeth, jaws calibrated at 5.0 mm intervals, 8-1/4" (21.0 cm), jaw base 6.0 mm
NOVO SURGICAL, INC.
5565-40
Not in Commercial Distribution

  • 00842331117824 ()

  • Length: 21 Centimeter
5565-40

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

Novo Surgical - 00842331116520

Cooley Vascular Clamp, angled shanks, jaws calibrated at 5.0 mm intervals, 6-1/2" (16.5 cm), 60 degree angle, large jaws
NOVO SURGICAL, INC.
5550-30
Not in Commercial Distribution

  • 00842331116520 ()

  • Length: 16.5 Centimeter
5550-30

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

Novo Surgical - 00842331116513

Cooley Vascular Clamp, angled shanks, jaws calibrated at 5.0 mm intervals, 6-1/2" (16.5 cm), 60 degree angle, small jaws
NOVO SURGICAL, INC.
5550-29
Not in Commercial Distribution

  • 00842331116513 ()

  • Length: 16.5 Centimeter
5550-29

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

Novo Surgical - 00842331116506

Cooley Vascular Clamp, angled shanks, jaws calibrated at 5.0 mm intervals, 6-1/2" (16.5 cm), 90 degree angle, large jaws
NOVO SURGICAL, INC.
5550-28
Not in Commercial Distribution

  • 00842331116506 ()

  • Length: 16.5 Centimeter
5550-28

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

Novo Surgical - 00842331116490

Cooley Vascular Clamp, angled shanks, jaws calibrated at 5.0 mm intervals, 6-1/2" (16.5 cm), 90 degree angle, small jaws
NOVO SURGICAL, INC.
5550-27
Not in Commercial Distribution

  • 00842331116490 ()

  • Length: 16.5 Centimeter
5550-27

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

Novo Surgical - 00842331115967

Cooley Coarctation Clamp - 6 3/4", jaws calibrated at 5.0 mm intervals, 6-3/4" (17.1 cm), angled shanks, straight jaws
NOVO SURGICAL, INC.
5550-12
Not in Commercial Distribution

  • 00842331115967 ()

  • Length: 17.1 Centimeter
5550-12

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

Novo Surgical - 00842331115950

Cooley Coarctation Clamp - 6 3/4", jaws calibrated at 5.0 mm intervals, 6-3/4" (17.1 cm), straight shanks, spoon jaws
NOVO SURGICAL, INC.
5550-11
Not in Commercial Distribution

  • 00842331115950 ()

  • Length: 17.1 Centimeter
5550-11

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

Novo Surgical - 00842331115943

Cooley Coarctation Clamp - 6 3/4", jaws calibrated at 5.0 mm intervals, 6-3/4" (17.1 cm), straight shanks, curved jaws
NOVO SURGICAL, INC.
5550-10
Not in Commercial Distribution

  • 00842331115943 ()

  • Length: 17.1 Centimeter
5550-10

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

Novo Surgical - 00842331115936

Cooley Coarctation Clamp - 6 3/4", jaws calibrated at 5.0 mm intervals, 6-3/4" (17.1 cm), straight shanks, straight jaws
NOVO SURGICAL, INC.
5550-09
Not in Commercial Distribution

  • 00842331115936 ()

  • Length: 17.1 Centimeter
5550-09

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

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

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

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

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

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

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

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

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

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

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® - 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

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

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

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

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

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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