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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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Resp-O2 Hygroscopic Condenser Humidifier HMEF 1500 B/V Filter, CO2 Port and Flex - 00840117305359

Adult, Tidal Volume Range(250-1500mL), Media(Foam + Flat Media), Dead Space(89 (60)mL, Breathing Resistance(2.0cm H2O at 60L /min), Weight (45g)
Dynarex Corporation
30106
In Commercial Distribution

  • 00840117305366 ()
  • 00840117305359 ()


  • Heat/moisture exchanger/microbial medical gas filter

Resp-O2 Advantage Filter- Universal Respiratory B/V Filter - 00840117305861

Bacterial: 99.998%, Viral: 99.96%, Adult/Ped : Tidal Volume Range(150-1500mL), Breathing Resistance(1.4cm H2O at 60 L/min), Dead Space(45mL), Weight(21g)
Dynarex Corporation
30400
In Commercial Distribution

  • 00840117305878 ()
  • 00840117305861 ()


  • Heat/moisture exchanger insertable filter

Ambler Surgical - 00190660004279

Gimbel irrigating cannula, 30 gauge, straight, U-shaped tip for cortex removal at the 12 o'clock position, front opening, 28.0mm overall length excluding hub
AMBLER SURGICAL CORP.
Gimbel irrigating cannula
In Commercial Distribution

  • 00190660004279 ()
1419E

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

Ambler Surgical - 00190660003814

Drews capsule polisher cannula, 25 gauge, angled, 2.5mm posterior sandblasted ring tip, 0.2mm irrigating port at 6 o'clock, 23.0mm overall length excluding hub
AMBLER SURGICAL CORP.
Drews capsule polisher cannula
In Commercial Distribution

  • 00190660003814 ()
1135E

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

DG Therm - 08437014205169

DG THERM Incubator is a device specifically designed to incubate DG Gel 8 Cards and/or test tubes at 37oC for inmmunohematology applications.
DIAGNOSTIC GRIFOLS SA
213734
In Commercial Distribution

  • 08437014205169 ()
213734

  • Microplate/tube/assay card incubator IVD

Hayden Medical - 00840319753705

Lighted Retractor 4" (10cm), 12mm x 50mm blade, polished surface at light source output, fiberoptic with universal light connector and modified 8fr suction
Hayden Medical, Inc.
210-512TR
In Commercial Distribution

  • 00840319753705 ()
210-512TR

  • Hand-held surgical retractor, reusable

Hayden Medical - 00840319726884

Pierse-Colibri Corneal Forceps Very Delicate 1x1 Teeth set at 45 Degree, .1mm (.25mm hole), oval hole flat handle, 75mm overall length, stainless steel
Hayden Medical, Inc.
E5-6253
In Commercial Distribution

  • 00840319726884 ()
E5-6253

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

Hayden Medical - 00840319726839

Colibri Forceps Very Delicate .12mm 1x2 Teeth, 2mm angled tips set at 45 degree with 6mm tying platform, 73mm overall length, stainless steel
Hayden Medical, Inc.
E5-6153
In Commercial Distribution

  • 00840319726839 ()
E5-6153

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

ACTEON - 03609820000657

The AS3D tip is intended for apical surgery of anterior teeth. It should be used without pressure, at the lowest possible effective power.
SATELEC
TIP AS3D
In Commercial Distribution

  • 03609820000657 ()
F00065

  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal

Rumex - 00840159904008

Whitehouse Gravity Axis Marker, Straight, Marks at 3, 6, 9 o'clock, 11.00/14.00 mm, Length 152 mm, Titanium Handle, Stainless Steel Gravity System
RUMEX INTERNATIONAL CORP.
3-1931
In Commercial Distribution

  • 00840159904008 ()
3-1931

  • Corneal marker, reusable
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