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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Bonn suturing forceps, 2 7/8'', straight shafts, 0.12mm 1x2 teeth set at 90 degrees, 5.0mm tying platforms, narrow handle
AMBLER SURGICAL CORP.
Bonn suturing forceps
In Commercial Distribution

  • 00190660041786 ()
2266E

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Castroviejo colibri corneal forceps, 4 1/4'', 0.12mm 1x2 teeth set at 45 degrees, 6.0mm tying platforms, wide flat handle
AMBLER SURGICAL CORP.
Castroviejo colibri corneal forceps
In Commercial Distribution

  • 00190660042929 ()
2233E

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
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
Seeley Hydrodissection Cannula 26ga, Angled 12mm from bend to tip at 45 Degree, Flattened 2mm Horizontal Tip, 12mm Overall Length
Crestpoint Management Limited
CA436
In Commercial Distribution

  • G412CA4360 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Healon/Viscoelastic Injection Cannula 21ga, Flattened Round Tip, Angled 5mm from bend to tip at 40 degree, 29mm Overall Length
Crestpoint Management Limited
CA320
In Commercial Distribution

  • G412CA3200 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Anis Cortex Aspirating Cannula 23gatw Angled 35 Degree at 1.5mm from bend to tip, .4mm Port, 26mm Overall Length, Sandblasted
Crestpoint Management Limited
CA292
In Commercial Distribution

  • G412CA2920 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Buratto Hydrodissectional Cannula 25ga Flattened .6mm tip, Angled/Vaulted 14mm from bend to tip at 50 Degrees, 18mm Overall Length
Crestpoint Management Limited
CA1631
In Commercial Distribution

  • G412CA16310 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, 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
Fogla Fine-Pointed Dissector, Angled 60 Degree at 5mm from bend to tip, Round Knurled Handle, 114mm Overall Length, Stainless Steel
Crestpoint Management Limited
PH6606
In Commercial Distribution

  • G412PH66060 ()


  • Soft-tissue surgical hook, reusable
TTI-McPherson Tying Forceps Angled 10.5mm at 45 Degree, with 10mm Smooth Tying Platform, Round Knurled Handle, 105mm Overall Length, Titanium
Crestpoint Management Limited
PH2443T
In Commercial Distribution

  • G412PH2443T0 ()


  • Ophthalmic surgical device handling forceps, reusable
Thrombinator™ System
ARTHREX, INC.
ABS-10080
In Commercial Distribution

  • 00888867286580 ()
ABS-10080

  • Haematological concentrate system preparation kit, thrombin separation
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
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
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
RF Frequency Filter
BOSTON SCIENTIFIC CORPORATION
M0041212H0
In Commercial Distribution

  • 08714729854395 ()


  • Electronic signal frequency filter
RF Frequency Filter
BOSTON SCIENTIFIC CORPORATION
M00412120
In Commercial Distribution

  • 08714729847939 ()


  • Electronic signal frequency filter
RF Filter Module For CLEARSIGN™ Amplifier
BOSTON SCIENTIFIC CORPORATION
M00420012300
In Commercial Distribution

  • 08714729882961 ()


  • Electronic signal frequency filter
VECTRA GEN 4C STIM W/O EMG PK
DJO, LLC
2873
In Commercial Distribution

  • 00888912296939 ()


  • Interferential electrical stimulation system electrode
VECTRA GEN 2C STIM W/O EMG PK
DJO, LLC
2871
In Commercial Distribution

  • 00888912296847 ()


  • Interferential electrical stimulation system electrode
LEGEND XT 4CH STIM PKG US STD
DJO, LLC
2786
In Commercial Distribution

  • 00888912294140 ()


  • Interferential electrical stimulation system electrode
VECTRA GENISYS 2CH STIM PKG
DJO, LLC
2764
In Commercial Distribution

  • 00888912293051 ()


  • Interferential electrical stimulation system electrode
Pro Carbon IFC Electrodes - 4" Round 1pair
C.M.P. Canadian Medical Products Inc
C5140
In Commercial Distribution

  • B312C51400 ()


  • Interferential electrical stimulation system electrode
Pro Carbon IFC Electrodes - 3" Round 1pair
C.M.P. Canadian Medical Products Inc
C5130
In Commercial Distribution

  • B312C51300 ()


  • Interferential electrical stimulation system electrode
Pro Carbon IFC Electrodes - 2" Round 1pair
C.M.P. Canadian Medical Products Inc
C5120
In Commercial Distribution

  • B312C51200 ()


  • Interferential electrical stimulation system electrode
No Description
EASY HEALTHCARE CORPORATION
ETP019
In Commercial Distribution

  • 10810038634361 ()
  • 00810038634364 ()


  • Interferential electrical stimulation system electrode
No Description
EASY HEALTHCARE CORPORATION
ETP538
In Commercial Distribution

  • 00810038630052 ()


  • Interferential electrical stimulation system electrode
No Description
EASY HEALTHCARE CORPORATION
ETP505
In Commercial Distribution

  • 00810038630038 ()


  • Interferential electrical stimulation system electrode
No Description
EASY HEALTHCARE CORPORATION
ETP015B
In Commercial Distribution

  • 10810038636129 ()
  • 00810038636122 ()


  • Interferential electrical stimulation system electrode
The Adhesive Electrodes are intended for use as a reusable, conductive adhesive interface between the patient’s skin and the marketed electrical stimulators (i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current. The electrode is for OTC (Over-The-Counter) or Prescription use.
ADP HEALTH LIMITED
EB2M20
In Commercial Distribution

  • 00860012809820 ()
EB2M20CO2

  • Interferential electrical stimulation system electrode
The Adhesive Electrodes are intended for use as a reusable, conductive adhesive interface between the patient’s skin and the marketed electrical stimulators (i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current. The electrode is for OTC (Over-The-Counter) or Prescription use.
ADP HEALTH LIMITED
EB2720
In Commercial Distribution

  • 00860012809813 ()
EB2720C21

  • Interferential electrical stimulation system electrode
2x4" rectangle white non-woven fabric cutaneous hydrogel electrode, package contains 4 individual electrodes.
ELITE MEDICAL SUPPLY OF NY
SF50100WP
In Commercial Distribution

  • 00860019001654 ()

  • Length: 4 Inch
  • Width: 2 Inch


  • Interferential electrical stimulation system electrode
2" square white non-woven fabric cutaneous hydrogel electrode, package contains 4 individual electrodes.
ELITE MEDICAL SUPPLY OF NY
SF5050WP
In Commercial Distribution

  • 00860019001616 ()

  • Width: 2 Inch
  • Length: 2 Inch


  • Interferential electrical stimulation system electrode
The Adhesive Electrodes are intended for use as a reusable, conductive adhesive interface between the patient’s skin and the marketed electrical stimulators (i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current. The electrode is for OTC (Over-The-Counter) or Prescription use.
ADP HEALTH LIMITED
EB2010
In Commercial Distribution

  • 00860012809837 ()
EB2010C21

  • Interferential electrical stimulation system electrode
No Description
EASY HEALTHCARE CORPORATION
ETP101
In Commercial Distribution

  • 10850253007786 ()
  • 00850253007789 ()
  • 30850253007780 ()


  • Interferential electrical stimulation system electrode
No Description
EASY HEALTHCARE CORPORATION
ETP538
In Commercial Distribution

  • 00850253007178 ()
  • 00850253007239 ()
  • 10850253007236 ()


  • Interferential electrical stimulation system electrode
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