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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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Quantum Blue Nitrile Exam Gloves - 10810063754935

Quantum Blue nitrile exam gloves, cobalt blue, x-large, 100/box
SAFCO DENTAL SUPPLY CO.
8210005
In Commercial Distribution

  • 00810063754938 ()
  • 10810063754935 ()
KXL

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Quantum Blue Nitrile Exam Gloves - 10810063754928

Quantum Blue nitrile exam gloves, cobalt blue, large, 100/box
SAFCO DENTAL SUPPLY CO.
8210004
In Commercial Distribution

  • 00810063754921 ()
  • 10810063754928 ()
KL

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Quantum Blue Nitrile Exam Gloves - 10810063754911

Quantum Blue nitrile exam gloves, cobalt blue, medium, 100/box
SAFCO DENTAL SUPPLY CO.
8210003
In Commercial Distribution

  • 00810063754914 ()
  • 10810063754911 ()
KM

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Quantum Blue Nitrile Exam Gloves - 10810063754904

Quantum Blue nitrile exam gloves, cobalt blue, small, 100/box
SAFCO DENTAL SUPPLY CO.
8210002
In Commercial Distribution

  • 00810063754907 ()
  • 10810063754904 ()
KS

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Quantum Blue Nitrile Exam Gloves - 10810063754898

Quantum Blue nitrile exam gloves, cobalt blue, x-small, 100/box
SAFCO DENTAL SUPPLY CO.
8210014
In Commercial Distribution

  • 00810063754891 ()
  • 10810063754898 ()
KXS

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

APO CAL - 05055273204414

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

Sontro Self-Fitting OTC Hearing Aids - 00850016231178

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

Sontro Self-Fitting OTC Hearing Aids - 00850016231161

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

Sontro Self-Fitting OTC Hearing Aids - 00850016231086

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

Sontro Self-Fitting OTC Hearing Aids - 00850016231079

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

Crypto/Giardia Human Fecal Direct Fluorescent Antigen Detection Kit - 00854624006005

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)

Quantum Intersegmental Table - 00850020142415

No Description
PIVOTAL HEALTH SOLUTIONS, INC.
Q400
In Commercial Distribution

  • 00850020142415 ()


  • Traction table, line-powered

Quantum 6000Z HD - 00606509200110

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) - 08885022060018

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

QUANTUM™* FLEX - 00846468022471

ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
13-55-PR-90
Not in Commercial Distribution

  • 00846468022471 ()


  • Bone-screw internal spinal fixation system, non-sterile

QUANTUM™* FLEX - 00846468022464

ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
13-55-PR-80
Not in Commercial Distribution

  • 00846468022464 ()


  • Bone-screw internal spinal fixation system, non-sterile

QUANTUM™* FLEX - 00846468022457

ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
13-55-PR-70
Not in Commercial Distribution

  • 00846468022457 ()


  • Bone-screw internal spinal fixation system, non-sterile

QUANTUM™* FLEX - 00846468022440

ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
13-55-PR-60
Not in Commercial Distribution

  • 00846468022440 ()


  • Bone-screw internal spinal fixation system, non-sterile

QUANTUM™* FLEX - 00846468022433

ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
13-55-PR-55
Not in Commercial Distribution

  • 00846468022433 ()


  • Bone-screw internal spinal fixation system, non-sterile

QUANTUM™* FLEX - 00846468022426

ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
13-55-PR-50
Not in Commercial Distribution

  • 00846468022426 ()


  • Bone-screw internal spinal fixation system, non-sterile
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