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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 - D948PBXPRN251

.07v taper NiTi reciprocating endodontic file, size primary, 25mm length
Smarter Alloys Inc
PR
In Commercial Distribution

  • D948PBXPRN250 ()
  • D948PBXPRN251 ()
PBX-PR-N25

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

Paradigm Quantum - D948PBXPRH251

.07v taper NiTi reciprocating endodontic file, size primary, 25mm length, heat treated
Smarter Alloys Inc
PRHT
In Commercial Distribution

  • D948PBXPRH250 ()
  • D948PBXPRH251 ()
PBX-PR-H25

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

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 2 - 00817470001594

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

  • 00817470001594 ()
28168-59

  • Electrosurgical system generator

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

RJL Quantum - B202QX0

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

  • B202QX0 ()
QX

  • Bioelectrical body composition analyser

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

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 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

STRABISMUS SCISSORS - 00192896082434

STRABISMUS SCISSORS CURVED BLADE POWER CUT GOLD QUANTUM
SONTEC INSTRUMENTS, INC.
1200-022Q
In Commercial Distribution

  • 00192896082434 ()

  • Length: 4.5 Inch
1200-022Q

  • General-purpose surgical scissors, reusable

IRIS SCISSORS - 00192896081376

IRIS SCISSORS GOLD RINGS CURVED 4.50 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1100-350JQ
In Commercial Distribution

  • 00192896081376 ()

  • Length: 4.5 Inch
1100-350JQ

  • Intraocular scissors, conventional-hinge, reusable

KAYE BLEPHAROPLASTY SCISSORS - 00192896081345

KAYE BLEPHAROPLASTY SCISSORS CURVED TUNGSTEN CARBIDE BLADE QUANTUM
SONTEC INSTRUMENTS, INC.
112-603Q
In Commercial Distribution

  • 00192896081345 ()

  • Length: 4.5 Inch
112-603Q

  • General-purpose surgical scissors, reusable

KNOWLES BANDAGE SCISSORS - 00192896081284

KNOWLES BANDAGE SCISSORS ANGLED SERRATED 5.50 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1100-208Q
In Commercial Distribution

  • 00192896081284 ()

  • Length: 5.5 Inch
1100-208Q

  • Bandage scissors, reusable

NELSON-METZENBAUM SCISSORS - 00192896075849

NELSON-METZENBAUM SCISSORS TUNGSTEN CARBIDE CURVED 16.0 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1100-849Q
In Commercial Distribution

  • 00192896075849 ()

  • Length: 16 Inch
1100-849Q

  • Suture scissors

ADSON DRESSING FORCEPS - 00192896032514

ADSON DRESSING FORCEPS SERR 4 3/4" QUANTUM
SONTEC INSTRUMENTS, INC.
136-660Q
In Commercial Distribution

  • 00192896032514 ()

  • Length: 4.75 Inch
136-660Q

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

IRIS SCISSORS - 00192896083516

IRIS SCISSORS CURVED BLADE POWER CUT GOLD QUANTUM
SONTEC INSTRUMENTS, INC.
1200-028Q
In Commercial Distribution

  • 00192896083516 ()

  • Length: 4.5 Inch
1200-028Q

  • Intraocular scissors, conventional-hinge, reusable

IRIS SCISSORS - 00192896083509

IRIS SCISSORS STRAIGHT BLADE POWER CUT GOLD QUANTUM
SONTEC INSTRUMENTS, INC.
1200-026Q
In Commercial Distribution

  • 00192896083509 ()

  • Length: 4.5 Inch
1200-026Q

  • Intraocular scissors, conventional-hinge, reusable

CASTROVIEJO NEEDLE HOLDER - 00192896091016

CASTROVIEJO NEEDLE HOLDER WITH LOCK STRAIGHT TIP QUANTUM
SONTEC INSTRUMENTS, INC.
15-1860Q
In Commercial Distribution

  • 00192896091016 ()
15-1860Q

  • Suturing needle holder, reusable

ETHMOID RONGEUR - 00192896090804

ETHMOID RONGEUR PEDIATRIC SIZE MICRO STRAIGHT TIP QUANTUM
SONTEC INSTRUMENTS, INC.
468-580Q
In Commercial Distribution

  • 00192896090804 ()

  • Length: 4 Inch
  • 2.5 Millimeters Tip
468-580Q

  • Craniofacial rongeur, reusable

MICRO BIOPSY FORCEPS - 00192896090477

MICRO BIOPSY FORCEPS DELICATE STRAIGHT OVAL CUP QUANTUM
SONTEC INSTRUMENTS, INC.
469-070Q
In Commercial Distribution

  • 00192896090477 ()

  • Length: 3.5 Inch
  • 0.9 x 1.2 Millimeter Tip
469-070Q

  • Rigid endoscopic biopsy forceps, reusable
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