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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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Vienna Nasal Speculum - 00192896107816

Vienna Nasal Speculum #3 Large Size 32 Millimeters Tip Quantum
SONTEC INSTRUMENTS, INC.
16-2360Q
In Commercial Distribution

  • 00192896107816 ()

  • Length: 5.75 Inch


  • Nasal speculum, reusable

Vienna Nasal Speculum - 00192896107809

Vienna Nasal Speculum #1 Small Size 24 Millimeters Blades Quantum
SONTEC INSTRUMENTS, INC.
16-2340Q
In Commercial Distribution

  • 00192896107809 ()

  • Length: 5.75 Inch


  • Nasal speculum, reusable

Laryngoscopy Forceps - 00192896107670

Laryngoscopy Forceps Conical Tube 1 Millimeter Shaft Straight Grasping Quantum
SONTEC INSTRUMENTS, INC.
1301-200Q
In Commercial Distribution

  • 00192896107670 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable

Laryngoscopy Scissors - 00192896107663

Laryngoscopy Scissors Conical Tube 2 Millimeters Shaft Curved Right Quantum
SONTEC INSTRUMENTS, INC.
1301-122Q
In Commercial Distribution

  • 00192896107663 ()

  • Length: 9 Inch


  • Flexible endoscopic scissors, reusable

Laryngoscopy Scissors - 00192896107267

Laryngoscopy Scissors Conical Tube 2 Millimeters Shaft Straight Horizontal Quantum
SONTEC INSTRUMENTS, INC.
1301-114Q
In Commercial Distribution

  • 00192896107267 ()

  • Length: 9 Inch


  • Flexible endoscopic scissors, reusable

Laryngoscopy Forceps - 00192896107212

Laryngoscopy Forceps Conical Tube 2 Millimeters Shaft Straight Grasping Quantum
SONTEC INSTRUMENTS, INC.
1301-242Q
In Commercial Distribution

  • 00192896107212 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable

Laryngoscopy Forceps - 00192896107205

Laryngoscopy Forceps Conical Tube 2 Millimeters Shaft Angled Up Quantum
SONTEC INSTRUMENTS, INC.
1301-246Q
In Commercial Distribution

  • 00192896107205 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable

Laryngoscopy Forceps - 00192896107199

Laryngoscopy Forceps Conical Tube 2 Millimeters Shaft Straight Horizontal Quantum
SONTEC INSTRUMENTS, INC.
1301-244Q
In Commercial Distribution

  • 00192896107199 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable

Laryngoscopy Forceps - 00192896107137

LARYNGOSCOPY FORCEPS CONICAL TUBE 1 MILLIMETER SHAFT STRAIGHT ALLIGATOR QUANTUM
SONTEC INSTRUMENTS, INC.
1301-208Q
In Commercial Distribution

  • 00192896107137 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable

House-Bellucci Ear Scissors - 00192896106994

HOUSE-BELLUCCI EAR SCISSORS DELICATE 6 MILLIMETER BLADES CURVED RIGHT QUANTUM
SONTEC INSTRUMENTS, INC.
469-096Q
In Commercial Distribution

  • 00192896106994 ()

  • Length: 3.5 Inch


  • Ear scissors, reusable

Killian Septum Speculum - 00192896117709

Killian Septum Speculum W/Fiber Optic Light Thin Low-Profile Quantum
SONTEC INSTRUMENTS, INC.
465-313QL
In Commercial Distribution

  • 00192896117709 ()

  • Length: 5.5 Inch
  • Blade Length 3.0 Inch
465-313QL

  • Nasal speculum, reusable

Killian Septum Speculum - 00192896117679

Killian Septum Speculum W/Fiber Optic Light Thin Low-Profile Quantum
SONTEC INSTRUMENTS, INC.
465-309QL
In Commercial Distribution

  • 00192896117679 ()

  • Length: 5.5 Inch
  • Blade Length 2.0 Inch
465-309QL

  • Nasal speculum, reusable

Killian Septum Speculum - 00192896117662

Killian Septum Speculum W/Fiber Optic Light Thin Low-Profile Quantum
SONTEC INSTRUMENTS, INC.
465-311QL
In Commercial Distribution

  • 00192896117662 ()

  • Blade Length 2.5 Inch
  • Length: 5.5 Inch
465-311QL

  • Nasal speculum, reusable

Stratte Needle Holder - 00192896117518

Stratte Needle Holder Reverse Angled Tungsten Carbide Serrated Tip Quantum
SONTEC INSTRUMENTS, INC.
2300-488LQ
In Commercial Distribution

  • 00192896117518 ()

  • Length: 10.5 Inch
2300-488LQ

  • Suturing needle holder, reusable

Stratte Needle Holder - 00192896117501

Stratte Needle Holder Right Angled Tungsten Carbide Serrated Tip Quantum
SONTEC INSTRUMENTS, INC.
2300-488RQ
In Commercial Distribution

  • 00192896117501 ()

  • Length: 10.5 Inch
2300-488RQ

  • Suturing needle holder, reusable

Operating Scissors - 00192896117433

Operating Scissors Classic Left Handed Straight Sharp/Blunt Blade Quantum
SONTEC INSTRUMENTS, INC.
1100-214LQ
In Commercial Distribution

  • 00192896117433 ()

  • Length: 5.5 Inch
1100-214LQ

  • General-purpose surgical scissors, reusable

Desmarres Chalazion Forceps - 00192896117297

Desmarres Chalazion Clamp Forceps Large Oval Solid Lower Blade Quantum
SONTEC INSTRUMENTS, INC.
14-9902Q
In Commercial Distribution

  • 00192896117297 ()

  • Lumen/Inner Diameter: 28 Millimeter
14-9902Q

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

MAYO HEGAR NEEDLE HOLDER - 00192896051676

MAYO HEGAR NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED STREAMLINED TIPS QUANTUM
SONTEC INSTRUMENTS, INC.
2300-716Q
In Commercial Distribution

  • 00192896051676 ()

  • Length: 6.25 Inch
2300-716Q

  • Suturing needle holder, reusable

NELSON-METZENBAUM SCISSORS - 00192896047044

NELSON-METZENBAUM SCISSORS LONG BLADES TUNGSTEN CARBIDE CURVED 18.0 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1100-850Q
In Commercial Distribution

  • 00192896047044 ()

  • Length: 18 Inch
1100-850Q

  • Suture scissors

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

QUANTUM™ CT Overlay - 10841962109052

Quantum CT - Siemens Somatom Definition 64 (for 240cm long cradle)
Qfix
RT-4550SS3
In Commercial Distribution

  • 10841962109052 ()

  • Length: 240 Centimeter
RT-4550SS3

  • Indexed-immobilization patient positioning system

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 - 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

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

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™* 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

QUANTUM™* FLEX - 00846468022419

ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
13-55-PR-45
Not in Commercial Distribution

  • 00846468022419 ()


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

QUANTUM™* FLEX - 00846468022402

ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
13-55-PR-40
Not in Commercial Distribution

  • 00846468022402 ()


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

QUANTUM™* FLEX - 00846468022396

ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
13-55-PR-35
Not in Commercial Distribution

  • 00846468022396 ()


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