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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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Biomet Orthopedics, LLC
2274-32-000
In Commercial Distribution

  • 00887868131653 ()
227432000

  • Surgical instrument handle, non-torque-limiting
MC 300 Nebulizer with Mouthpiece
Trudell Medical International
105550
Not in Commercial Distribution

  • 62860105550028 ()
  • 62860105550011 ()
10555094050

  • Nebulizing system delivery set, reusable
Mobile dental suction system
DÜRR DENTAL SE
ATH7100200
In Commercial Distribution

  • E247ATH71002000 ()


  • Dental suction system
Mobile dental suction system
DÜRR DENTAL SE
ATH7100100
In Commercial Distribution

  • E247ATH71001000 ()


  • Dental suction system
23ga Aspirator with Capsule Polisher
KATALYST SURGICAL LLC
1500-23
In Commercial Distribution

  • 00840096205831 ()


  • Ophthalmic working-channel cannula, reusable
23ga Irrigator With Iris Manipulator
KATALYST SURGICAL LLC
1400-23
In Commercial Distribution

  • 00840096205817 ()


  • Ophthalmic working-channel cannula, reusable
An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.
MEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETI
BC21090
In Commercial Distribution

  • 68697645010552 ()
  • 08697645010550 ()


  • Ventilator breathing circuit, single-use
An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.
MEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETI
BC21273
In Commercial Distribution

  • 68697645010071 ()
  • 08697645010079 ()


  • Ventilator breathing circuit, single-use
12-(12ml) Sperm Wash Modified HTF Medium w/Gentamicin
VITROLIFE INC.
15262
In Commercial Distribution

  • 10805360016855 ()
  • 00805360016858 ()

  • Total Volume: 12 Milliliter


  • Spermatozoa/semen motility medium supplement
The DRG neonatal Galactose ELISA is designed for the quantitative determination of galactose in neonatal blood spots. It is for in vitro diagnostic use as an aid in screening newborns for elevated galactose levels as seen in galactosemia.
DRG International Inc
EIA-1488
Not in Commercial Distribution

  • 00840239014887 ()
EIA-1488

  • Total galactose IVD, kit, spectrophotometry
The DRG Galactose kit is designed for the quantitative determination of galactose in neonatal blood spots. It is for in-vitro diagnostic use as an aid in screening newborns for the elevated galactose levels as seen in galactosemia.
DRG International Inc
EIA-1486
Not in Commercial Distribution

  • 00840239014863 ()
EIA-1486

  • Total galactose IVD, kit, spectrophotometry
Accessory handle used to insert instruments with AO connection.
ABANZA TECNOMED SL.
21
In Commercial Distribution

  • 08437019739324 ()
  • 28437019739328 ()


  • Surgical instrument handle, non-torque-limiting
Antimicrobial clear silicone adhesive dressing
Covalon Technologies Ltd
TWBD1011
In Commercial Distribution

  • 00825439010143 ()
  • 00825439010136 ()
  • 10825439010140 ()

  • Length: 4 Centimeter
  • Width: 4 Centimeter


  • Antimicrobial synthetic polymer semi-permeable film dressing, adhesive
Pivoting Showerhead, Matte Black Finish
WATER PIK, INC.
PHO-555E
In Commercial Distribution

  • 00073950339346 ()
PHO-555E

  • External manual massager, home-use
Pivoting Showerhead, Brushed Nickel Finish
WATER PIK, INC.
PHO-559ME
In Commercial Distribution

  • 00073950339322 ()
PHO-559ME

  • External manual massager, home-use
Pivoting Showerhead, Chrome Finish
WATER PIK, INC.
PHO-553ME
In Commercial Distribution

  • 00073950339230 ()
PHO-553ME

  • External manual massager, home-use
Pivoting Showerhead, White Finish
WATER PIK, INC.
PHR-551E
In Commercial Distribution

  • 00073950338011 ()
PHR-551E

  • External manual massager, home-use
Pivoting Showerhead, Nickel Finish
WATER PIK, INC.
PHR-559E
In Commercial Distribution

  • 00073950337960 ()
PHR-559E

  • External manual massager, home-use
Pivoting Showerhead, Chrome Finish
WATER PIK, INC.
PHR-553E
In Commercial Distribution

  • 00073950337885 ()
PHR-553E

  • External manual massager, home-use
Hand held adjustable height shower head, brushed nickel
WATER PIK, INC.
XDL-769ME
In Commercial Distribution

  • 00073950291040 ()
XDL-769ME

  • External manual massager, home-use
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