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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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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

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

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

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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