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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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Paradigm Quantum - D948PBXMDN251

.06v taper NiTi reciprocating endodontic file, size medium, 25mm length
Smarter Alloys Inc
MD
In Commercial Distribution

  • D948PBXMDN250 ()
  • D948PBXMDN251 ()
PBX-MD-N25

  • Rotary/reciprocating endodontic file/rasp, single-use

Paradigm Quantum - D948PBXMDH251

.06v taper NiTi reciprocating endodontic file, size medium, 25mm length, heat treated
Smarter Alloys Inc
MDHT
In Commercial Distribution

  • D948PBXMDH250 ()
  • D948PBXMDH251 ()
PBX-MD-H25

  • Rotary/reciprocating endodontic file/rasp, single-use

Paradigm Quantum - D948PBXLGN251

.05v taper NiTi reciprocating endodontic file, size large, 25mm length
Smarter Alloys Inc
LG
In Commercial Distribution

  • D948PBXLGN250 ()
  • D948PBXLGN251 ()
PBX-LG-N25

  • Rotary/reciprocating endodontic file/rasp, single-use

Paradigm Quantum - D948PBXLGH251

.05v taper NiTi reciprocating endodontic file, size large, 25mm length, heat treated
Smarter Alloys Inc
LGHT
In Commercial Distribution

  • D948PBXLGH250 ()
  • D948PBXLGH251 ()
PBX-LG-H25

  • Rotary/reciprocating endodontic file/rasp, single-use

Quantum Rival - 00606509200134

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
R44/Lightning/Rival RQ/Partner/Lightning EVO
In Commercial Distribution

  • 00606509200134 ()
N/A

  • Electric-motor-driven wheelchair, occupant-controlled

Quantum 610 - 00606509200127

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
Q610
In Commercial Distribution

  • 00606509200127 ()
N/A

  • Electric-motor-driven wheelchair, occupant-controlled

Quantum 6000Z - 00606509200103

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
Q6000Z/Q6000ZRQ/Q600 Sport
In Commercial Distribution

  • 00606509200103 ()
N/A

  • Electric-motor-driven wheelchair, occupant-controlled

Quantum 1450 - 00606509200097

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 1450 / Q1450
In Commercial Distribution

  • 00606509200097 ()
N/A

  • Electric-motor-driven wheelchair, occupant-controlled

Quantum® - 05020583920002

Cell Expansion System
TERUMO BCT, INC.
92000
Not in Commercial Distribution

  • 05020583920002 ()


  • Blood/tissue storage/culture container

Quantum® - 05020583210240

Quantum System Cell Expansion Set and Accessories, 200 Micron In-Line Filter Accessory Set
TERUMO BCT, INC.
21024
Not in Commercial Distribution

  • 05020583210240 ()
  • 35020583210241 ()


  • Blood/tissue storage/culture container

Quantum ® - 05020583210233

Quantum System Cell Expansion Set and Accessories, Waste Bag 4L, Accessory Set
TERUMO BCT, INC.
21023
Not in Commercial Distribution

  • 05020583210233 ()
  • 35020583210234 ()


  • Blood/tissue storage/culture container

Quantum® - 05020583210219

Quantum System Cell Expansion Set and Accessories, Media Bag 4 L, Accessory Set
TERUMO BCT, INC.
21021
Not in Commercial Distribution

  • 05020583210219 ()
  • 35020583210210 ()


  • Blood/tissue storage/culture container

Quantum® - 05020583210202

Quantum System Cell Expansion Set and Accessories, Cell Inlet Bag 0.5 L, Accessory Set
TERUMO BCT, INC.
21020
Not in Commercial Distribution

  • 05020583210202 ()
  • 35020583210203 ()


  • Blood/tissue storage/culture container

Quantum® - 05020583210127

Quantum System Cell Expansion Set and Accessories, Cell Expansion Set
TERUMO BCT, INC.
21012
Not in Commercial Distribution

  • 05020583210127 ()
  • 35020583210128 ()


  • Blood/tissue storage/culture container

QUANTUM 2 - 00817470001594

RF12000 Q2 SERVICE CONTROLLER-ONLY PACKAGE
Smith & Nephew, Inc.
28168-59
In Commercial Distribution

  • 00817470001594 ()
28168-59

  • Electrosurgical system generator

Quantum S2 - G225QSSX370

The Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytospins, cell smears and fine needle aspirates. This universal system is designed to automate the manual staining methods routinely used in histology laboratories.
Pathcom Systems Corporation
QSS-X37
In Commercial Distribution

  • G225QSSX370 ()


  • Microscope slide stainer IVD

Quantum HDx - G225QHDX360

The Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytospins, cell smears and fine needle aspirates. This universal system is designed to automate the manual staining methods routinely used in histology laboratories.
Pathcom Systems Corporation
QHD-X36
In Commercial Distribution

  • G225QHDX360 ()


  • Microscope slide stainer IVD

RJL Quantum - B202QX0

No Description
R.J.L. SCIENCES, INC.
Quantum-X
In Commercial Distribution

  • B202QX0 ()
QX

  • Bioelectrical body composition analyser

RJL Quantum - B202Q5S0

No Description
R.J.L. SCIENCES, INC.
Quantum-V Segmental
In Commercial Distribution

  • B202Q5S0 ()
Q5S

  • Bioelectrical body composition analyser

RJL Quantum - B202Q50

No Description
R.J.L. SCIENCES, INC.
Quantum-V
In Commercial Distribution

  • B202Q50 ()
Q5

  • Bioelectrical body composition analyser

RJL Quantum - B202Q40

No Description
R.J.L. SCIENCES, INC.
Quantum-IV
In Commercial Distribution

  • B202Q40 ()
Q4

  • Bioelectrical body composition analyser

RJL Quantum - B202Q30

No Description
R.J.L. SCIENCES, INC.
Quantum-III
In Commercial Distribution

  • B202Q30 ()
Q3

  • Bioelectrical body composition analyser

RJL Quantum - B202Q20

No Description
R.J.L. SCIENCES, INC.
Quantum-II
In Commercial Distribution

  • B202Q20 ()
Q2

  • Bioelectrical body composition analyser

Apolipoprotein Control Serum CHD - 00842768021121

Assayed control for apolipoprotein A-I and B and CRP assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446469
In Commercial Distribution

  • 00842768021121 ()
  • 00842768018596 ()
OUPH09

  • Plasma protein IVD, control

K-ASSAY® Apo AI/B Calibrator - 00816426020542

For the calibration of the K-ASSAY® Apo AI and Apo B assays.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-008C
In Commercial Distribution

  • 00816426020542 ()
KAI-008C

  • Multiple lipid analyte IVD, calibrator

Quantum 4Front 2HD - 00606509200202

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 4Front 2HD
In Commercial Distribution

  • 00606509200202 ()
N/A

  • Electric-motor-driven wheelchair, occupant-controlled

Quantum 4Front 2 - 00606509200196

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 4Front 2
In Commercial Distribution

  • 00606509200196 ()
N/A

  • Electric-motor-driven wheelchair, occupant-controlled

RF Cable A1 - 07350021984517

For connecting Double Pump RF to S&N Dyonics RF, ArthroCare Atlas, ArthroCare Quantum and ArthroCare Quantum 2
INSIGHTRA MEDICAL, INC.
1402008
In Commercial Distribution

  • 07350021984517 ()


  • Electrical-only medical device connection cable, reusable

Nellcor - 20884522042137

Adult SpO2 Sensor,Two Piece
Covidien LP
AI
Not in Commercial Distribution

  • 10884522042130 ()
  • 20884522042137 ()

  • Patient Weight, >30, KG;


  • Transcutaneous blood gas monitor sensor

Wire Twister - 00192896121379

Wire Twister Tungsten Carbide Serrated Blunt Jaw Quantum
SONTEC INSTRUMENTS, INC.
2300-604Q
In Commercial Distribution

  • 00192896121379 ()

  • Length: 7 Inch
2300-604Q

  • Wire twister

McPherson-Westcott Conjunctival Scissors - 00192896121331

McPherson-Westcott Conjunctival Scissors Small Curved Blunt Blades Quantum
SONTEC INSTRUMENTS, INC.
13-3300Q
In Commercial Distribution

  • 00192896121331 ()

  • Length: 4 Inch
13-3300Q

  • Conjunctival scissors, reusable

Par Needle Holder - 00192896117723

Par Needle Holder Tungsten Carbide Serrated Tip Quantum
SONTEC INSTRUMENTS, INC.
132-367AQ
In Commercial Distribution

  • 00192896117723 ()

  • Length: 4.5 Inch
132-367AQ

  • Suturing needle holder, reusable

Webster Needle Holder - 00192896115606

Webster Needle Holder Tungsten Carbide Dust Tip Quantum
SONTEC INSTRUMENTS, INC.
2300-520Q
In Commercial Distribution

  • 00192896115606 ()

  • Length: 4.75 Inch
2300-520Q

  • Suturing needle holder, reusable

Derf Needle Holder - 00192896115583

Derf Needle Holder Tungsten Carbide Dust Tip Quantum
SONTEC INSTRUMENTS, INC.
132-365Q
In Commercial Distribution

  • 00192896115583 ()

  • Length: 4.75 Inch
132-365Q

  • Suturing needle holder, reusable

Operating Scissors - 00192896114661

Operating Scissors Classic Curved Sharp/Blunt Blades Quantum
SONTEC INSTRUMENTS, INC.
1100-226Q
In Commercial Distribution

  • 00192896114661 ()

  • Length: 5.5 Inch


  • General-purpose surgical scissors, reusable

Doyen Intestinal Forceps - 00192896112612

Doyen Intestinal Forceps Curved Longitudinal Serrated Tip Quantum
SONTEC INSTRUMENTS, INC.
142-202Q
In Commercial Distribution

  • 00192896112612 ()

  • Length: 9 Inch


  • Surgical soft-tissue manipulation forceps, scissors-like, reusable

Ryder Needle Holder - 00192896110953

Ryder Needle Holder Tungsten Carbide Serrated Left Quantum
SONTEC INSTRUMENTS, INC.
2300-310LQ
In Commercial Distribution

  • 00192896110953 ()

  • Length: 6 Inch
  • Jaw 1.5 Millimeter


  • Suturing needle holder, reusable

Mayo Dissecting Scissors - 00192896110809

Mayo Dissecting Scissors Beveled Blades Curved Left Quantum
SONTEC INSTRUMENTS, INC.
1100-254LQ
In Commercial Distribution

  • 00192896110809 ()

  • Length: 5.5 Inch
1100-254LQ

  • General-purpose surgical scissors, reusable

Parell Needle Holder - 00192896110786

Parell Needle Holder Tungsten Carbide Serrated Tip Quantum
SONTEC INSTRUMENTS, INC.
132-314Q
In Commercial Distribution

  • 00192896110786 ()

  • Length: 6 Inch


  • Suturing needle holder, reusable

Laryngeal Mirror - 00192896110304

Laryngeal Mirror With Handle 24 Millimeter #5 Quantum
SONTEC INSTRUMENTS, INC.
502-252Q
In Commercial Distribution

  • 00192896110304 ()

  • Length: 7 Inch


  • Laryngeal mirror, reusable

Laryngeal Mirror - 00192896110298

Laryngeal Mirror With Handle 20 Millimeter #3 Quantum
SONTEC INSTRUMENTS, INC.
502-248Q
In Commercial Distribution

  • 00192896110298 ()

  • Length: 7 Inch


  • Laryngeal mirror, reusable

Laryngeal Mirror - 00192896110281

Laryngeal Mirror With Handle 26 Millimeter #6 Quantum
SONTEC INSTRUMENTS, INC.
502-254Q
In Commercial Distribution

  • 00192896110281 ()

  • Length: 7 Inch


  • Laryngeal mirror, reusable

Laryngeal Mirror - 00192896110274

Laryngeal Mirror With Handle 28 Millimeter #7 Quantum
SONTEC INSTRUMENTS, INC.
502-256Q
In Commercial Distribution

  • 00192896110274 ()

  • Length: 7 Inch


  • Laryngeal mirror, reusable

Laryngeal Mirror - 00192896110267

Laryngeal Mirror With Handle 30 Millimeter #8 Quantum
SONTEC INSTRUMENTS, INC.
502-258Q
In Commercial Distribution

  • 00192896110267 ()

  • Length: 7 Inch


  • Laryngeal mirror, reusable

Laryngeal Mirror - 00192896110250

Laryngeal Mirror With Handle 22 Millimeter #4 Quantum
SONTEC INSTRUMENTS, INC.
502-250Q
In Commercial Distribution

  • 00192896110250 ()

  • Length: 7 Inch


  • Laryngeal mirror, reusable

Laryngeal Mirror - 00192896110243

Laryngeal Mirror With Handle 14 Millimeter #0 Quantum
SONTEC INSTRUMENTS, INC.
502-242Q
In Commercial Distribution

  • 00192896110243 ()

  • Length: 7 Inch


  • Laryngeal mirror, reusable

Laryngeal Mirror - 00192896110236

Laryngeal Mirror With Handle 12 Millimeter #00 Quantum
SONTEC INSTRUMENTS, INC.
502-240Q
In Commercial Distribution

  • 00192896110236 ()

  • Length: 7 Inch


  • Laryngeal mirror, reusable

Laryngeal Mirror - 00192896110229

Laryngeal Mirror With Handle 18 Millimeter #2 Quantum
SONTEC INSTRUMENTS, INC.
502-246Q
In Commercial Distribution

  • 00192896110229 ()

  • Length: 7 Inch


  • Laryngeal mirror, reusable

Laryngeal Mirror - 00192896110212

Laryngeal Mirror With Handle 10 Millimeter #000 Quantum
SONTEC INSTRUMENTS, INC.
502-238Q
In Commercial Distribution

  • 00192896110212 ()

  • Length: 7 Inch


  • Laryngeal mirror, reusable

Laryngeal Mirror - 00192896110205

Laryngeal Mirror With Handle 16 Millimeter #1 Quantum
SONTEC INSTRUMENTS, INC.
502-244Q
In Commercial Distribution

  • 00192896110205 ()

  • Length: 7 Inch


  • Laryngeal mirror, reusable
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