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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MICRO ALLIGATOR FORCEPS WITHOUT LOCK DELICATE STRAIGHT SERRATED TIP QUANTUM
SONTEC INSTRUMENTS, INC.
469-036Q
In Commercial Distribution

  • 00192896090378 ()

  • Length: 3 Inch
  • 4 x 0.9 Millimeter Tip
469-036Q

  • Surgical soft-tissue manipulation forceps, alligator, reusable
ADSON FORCEPS SERRATED HANDLE DELICATE SERRATED 0.8 MILLIMETER TIP QUANTUM
SONTEC INSTRUMENTS, INC.
136-662Q
In Commercial Distribution

  • 00192896105997 ()

  • Length: 4.75 Inch


  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
GORNEY SCISSORS DOUBLE BEVELED BLADE POWER CUT GOLD STRAIGHT QUANTUM
SONTEC INSTRUMENTS, INC.
1200-421Q
In Commercial Distribution

  • 00192896104808 ()

  • Length: 9 Inch


  • Nasal scissors
BUCK EAR CURETTE ROUND HANDLE BLUNT ANGLE SIZE 0 QUANTUM
SONTEC INSTRUMENTS, INC.
467-382Q
In Commercial Distribution

  • 00192896104488 ()

  • Length: 5.75 Inch


  • General-purpose curette
LISTER BANDAGE SCISSORS LARGE DOUBLE RING POWER CUT GOLD QUANTUM
SONTEC INSTRUMENTS, INC.
1200-207Q
In Commercial Distribution

  • 00192896100947 ()

  • Length: 7.25 Inch


  • Bandage scissors, reusable
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
BEIGE/990017-SWH; left (refurbished) replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990017-SWH
In Commercial Distribution

  • 00850016231178 ()


  • Air-conduction hearing aid, receiver-in-canal
BEIGE/990016-SWH; right (refurbished) replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990016-SWH
In Commercial Distribution

  • 00850016231161 ()


  • Air-conduction hearing aid, receiver-in-canal
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
No Description
IVD RESEARCH, INC.
C/G-DFA
In Commercial Distribution

  • 00854624006005 ()
C/G-DFA

  • Cryptosporidium species antigen IVD, kit, direct fluorescent test (DFT)
  • Giardia lamblia antigen IVD, kit, direct fluorescent test (DFT)
ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
13-55-PR-90
Not in Commercial Distribution

  • 00846468022471 ()


  • Bone-screw internal spinal fixation system, non-sterile
ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
13-55-PR-80
Not in Commercial Distribution

  • 00846468022464 ()


  • Bone-screw internal spinal fixation system, non-sterile
ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
13-55-PR-70
Not in Commercial Distribution

  • 00846468022457 ()


  • Bone-screw internal spinal fixation system, non-sterile
ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
13-55-PR-60
Not in Commercial Distribution

  • 00846468022440 ()


  • Bone-screw internal spinal fixation system, non-sterile
ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
13-55-PR-55
Not in Commercial Distribution

  • 00846468022433 ()


  • Bone-screw internal spinal fixation system, non-sterile
ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
13-55-PR-50
Not in Commercial Distribution

  • 00846468022426 ()


  • Bone-screw internal spinal fixation system, non-sterile
ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
13-55-PR-45
Not in Commercial Distribution

  • 00846468022419 ()


  • Bone-screw internal spinal fixation system, non-sterile
ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
13-55-PR-40
Not in Commercial Distribution

  • 00846468022402 ()


  • Bone-screw internal spinal fixation system, non-sterile
ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
13-55-PR-35
Not in Commercial Distribution

  • 00846468022396 ()


  • Bone-screw internal spinal fixation system, non-sterile
ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
13-55-PR-120
Not in Commercial Distribution

  • 00846468022389 ()


  • Bone-screw internal spinal fixation system, non-sterile
ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
13-55-PR-110
Not in Commercial Distribution

  • 00846468022372 ()


  • Bone-screw internal spinal fixation system, non-sterile
ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
13-55-PR-100
Not in Commercial Distribution

  • 00846468022365 ()


  • Bone-screw internal spinal fixation system, non-sterile
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
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
No Description
PIVOTAL HEALTH SOLUTIONS, INC.
Q400
In Commercial Distribution

  • 00850020142415 ()


  • Traction table, line-powered
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
Ryder Needle Holder Tungsten Carbide Serrated 1.5 Millimeter Jaw Streamlined Quantum
SONTEC INSTRUMENTS, INC.
2300-307Q
In Commercial Distribution

  • 00192896109902 ()

  • Length: 5 Inch


  • Suturing needle holder, reusable
Laryngoscopy Forceps Conical Tube 1 Millimeter Shaft Angled Up Grasping Quantum
SONTEC INSTRUMENTS, INC.
1301-202Q
In Commercial Distribution

  • 00192896107151 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable
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