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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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Cottle osteotome, 7 1/4'', curved, 6.0mm wide, with markings at 4.0cm, 5.0cm, 6.0cm and 7.0cm, rounded corners, flat handle
AMBLER SURGICAL CORP.
Cottle osteotome
In Commercial Distribution

  • 00190660122683 ()
59-353

  • Nasal chisel
Cottle osteotome, 7 1/4'', curved, 4.0mm wide, with markings at 4.0cm, 5.0cm, 6.0cm and 7.0cm, rounded corners, flat handle
AMBLER SURGICAL CORP.
Cottle osteotome
In Commercial Distribution

  • 00190660122676 ()
59-351

  • Nasal chisel
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
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
AUSTIN Measuring probe(caliper)determine length of stapes prosthesis, 6 1/4" 160 mm, markings at 3.5 - 4.0 - 4.5 mm
RZ-Medizintechnik GmbH
410-142-166
In Commercial Distribution

  • 04049197304566 ()
410-142-166

  • General surgery wound probe/packer
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 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
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
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
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
Bone molder - used to compress bone in between dental Implants at time of placement - Offset to allow access to posterior
Suncoast Dental, Inc
Bone Molder - Offset
In Commercial Distribution

  • 00083208130137 ()
Bone Molder - Offset

  • Osteotomy compression/distraction instrument
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
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 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 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
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