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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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GREY/990008-SWH; left (refurbished) replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990008-SWH
In Commercial Distribution

  • 00850016231086 ()


  • Air-conduction hearing aid, receiver-in-canal
GREY/990007-SWH; right (refurbished) replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990007-SWH
In Commercial Distribution

  • 00850016231079 ()


  • Air-conduction hearing aid, receiver-in-canal
This product is intended for in-vitro use in the calibration of Apolipoprotein A-I and Apolipoprotein B assays.
RANDOX LABORATORIES LIMITED
LP3023
In Commercial Distribution

  • 05055273204414 ()
LP3023

  • Multiple apolipoprotein IVD, calibrator
No Description
PIVOTAL HEALTH SOLUTIONS, INC.
Q400
In Commercial Distribution

  • 00850020142415 ()


  • Traction table, line-powered
A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Pride Mobility Products Corp
Quantum 6000ZHD/Q6000ZHD/Q600 HD
In Commercial Distribution

  • 00606509200110 ()
N/A

  • Electric-motor-driven wheelchair, occupant-controlled
Quantum Mitohormesis (QMT) Medical Device is intended for: 1. Stimulating healthy limb muscles to improve and facilitate muscle performance. 2. Preventing or retardation of disuse atrophy of muscles.
QUANTUMTX PTE. LTD.
M2101
In Commercial Distribution

  • 18885022060015 ()
  • 08885022060018 ()


  • Muscle performance enhancement electromagnetic stimulator
Natus Quantum Stim Daisy Chain Cable, 1 to 2, 41 in
XLTEK
013769
In Commercial Distribution

  • 00382830016421 ()


  • Electrical-only medical device connection cable, reusable
Stevens Tenotomy Scissors Tungsten Carbide Power Cut Long Curved Blunt Quantum
SONTEC INSTRUMENTS, INC.
1200-499Q
In Commercial Distribution

  • 00192896110960 ()

  • Length: 4.5 Inch


  • Tenotome
LARYNGOSCOPY FORCEPS UP ANGLE HEART SHAPED TIP CONICAL TUBE SHAFT QUANTUM
SONTEC INSTRUMENTS, INC.
1301-264Q
In Commercial Distribution

  • 00192896095601 ()

  • 45 Degree Tip
  • Length: 9 Inch
  • 2 Millimeter Shaft
1301-264Q

  • Flexible endoscopic biopsy forceps, reusable
ALLIGATOR GRASPING FORCEPS DELICATE SHAFT DELICATE JAW LOCK 9.0 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1100-334Q
In Commercial Distribution

  • 00192896093645 ()

  • Length: 9 Inch
1100-334Q

  • Surgical soft-tissue manipulation forceps, alligator, reusable
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