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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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MR PHACO - G412CA16310

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

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

MR PHACO - G412PH66060

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

MR PHACO - G412PH2443T0

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

Arthrex® - 00888867286580

Thrombinator™ System
ARTHREX, INC.
ABS-10080
In Commercial Distribution

  • 00888867286580 ()
ABS-10080

  • Haematological concentrate system preparation kit, thrombin separation

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

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

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
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