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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Crile Wood Needle Holder Tungsten Carbide Serrated Tip Quantum
SONTEC INSTRUMENTS, INC.
132-217Q
In Commercial Distribution

  • 00192896109612 ()

  • Length: 11 Inch


  • Suturing needle holder, reusable
Olsen Webster Needle Holder Tungsten Carbide Serrated Tip Quantum
SONTEC INSTRUMENTS, INC.
132-362Q
In Commercial Distribution

  • 00192896109414 ()

  • Length: 4.5 Inch


  • Suturing needle holder, reusable
Killian Septum Speculum Thin Low-Profile 3.0 Inch Blades Quantum
SONTEC INSTRUMENTS, INC.
465-313Q
In Commercial Distribution

  • 00192896108776 ()

  • Length: 5.5 Inch
465-313Q

  • Nasal speculum, reusable
Killian Septum Speculum Thin Low-Profile 2.50 Inch Blades Quantum
SONTEC INSTRUMENTS, INC.
465-311Q
In Commercial Distribution

  • 00192896108769 ()

  • Length: 5.5 Inch
465-311Q

  • Nasal speculum, reusable
Killian Septum Speculum Thin Low-Profile 2.0 Inch Blades Quantum
SONTEC INSTRUMENTS, INC.
465-309Q
In Commercial Distribution

  • 00192896108752 ()

  • Length: 5.5 Inch
465-309Q

  • Nasal speculum, reusable
House-Bellucci Ear Scissors Delicate 5 Millimeter Blades Straight Quantum
SONTEC INSTRUMENTS, INC.
469-089Q
In Commercial Distribution

  • 00192896106987 ()

  • Length: 3.5 Inch


  • Ear scissors, reusable
HOUSE-BELLUCCI EAR SCISSORS DELICATE 8 MILLIMETER BLADES STRAIGHT QUANTUM
SONTEC INSTRUMENTS, INC.
469-093Q
In Commercial Distribution

  • 00192896106932 ()


  • Ear scissors, reusable
MICRO ALLIGATOR FORCEPS DOWN ANGLED JAW INOX STEEL QUANTUM
SONTEC INSTRUMENTS, INC.
469-046Q
In Commercial Distribution

  • 00192896041417 ()

  • Length: 3.25 Inch
  • 0.6 x 7 Millimeter Tip
469-046Q

  • Surgical soft-tissue manipulation forceps, alligator, reusable
BAINBRIDGE FORCEPS DELICATE CURVED LONGITUDINAL CROSS SERRATED TIP QUANTUM
SONTEC INSTRUMENTS, INC.
115-602Q
In Commercial Distribution

  • 00192896075658 ()

  • Length: 6 Inch
115-602Q

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
XactTrode Patient Cable, 64 Contact with Quantum Connector, 10ft
BLACKROCK MICROSYSTEMS, LLC
028921
In Commercial Distribution

  • 00814901021336 ()

  • Length: 10 Feet
028921

  • Electroencephalographic signal amplifier
XactTrode Patient Cable, 96 Contact with Quantum Connector, 10ft
BLACKROCK MICROSYSTEMS, LLC
029453
In Commercial Distribution

  • 00814901021312 ()

  • Length: 10 Feet
029453

  • Electroencephalographic signal amplifier
XactTrode Patient Cable, 32 Contact with Quantum Connector, 10ft
BLACKROCK MICROSYSTEMS, LLC
028920
In Commercial Distribution

  • 00814901021305 ()

  • Length: 10 Feet
028920

  • Electroencephalographic signal amplifier
XactTrode Patient Cable, 96 Contact with Quantum Connector, 6ft
BLACKROCK MICROSYSTEMS, LLC
029451
In Commercial Distribution

  • 00814901021299 ()

  • Length: 6 Feet
029451

  • Electroencephalographic signal amplifier
XactTrode Patient Cable, 64 Contact with Quantum Connector, 6ft
BLACKROCK MICROSYSTEMS, LLC
028919
In Commercial Distribution

  • 00814901021282 ()

  • Length: 6 Feet
028919

  • Electroencephalographic signal amplifier
XactTrode Patient Cable, 32 Contact with Quantum Connector, 6ft
BLACKROCK MICROSYSTEMS, LLC
028635
In Commercial Distribution

  • 00814901021275 ()

  • Length: 6 Feet
028635

  • Electroencephalographic signal amplifier
QUANTUM 43 IN X 43 IN FIXED NO-TILT WS
CARESTREAM HEALTH, INC.
QW-420
In Commercial Distribution

  • 60889974000085 ()
AA3396

  • X-ray film cassette holder
BEIGE/990014-SWH; left replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990014-SWH
In Commercial Distribution

  • 00850016231147 ()


  • Air-conduction hearing aid, receiver-in-canal
BEIGE/990013-SWH; right replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990013-SWH
In Commercial Distribution

  • 00850016231130 ()


  • Air-conduction hearing aid, receiver-in-canal
GREY/990005-SWH; left replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990005-SWH
In Commercial Distribution

  • 00850016231055 ()


  • Air-conduction hearing aid, receiver-in-canal
GREY/990004-SWH; right replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990004-SWH
In Commercial Distribution

  • 00850016231048 ()


  • Air-conduction hearing aid, receiver-in-canal
InferRead Lung CT.AI is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during the review of CT examinations of the chest.
Infervision Medical Technology Co., Ltd
5.0.2.5
In Commercial Distribution

  • 00850003095042 ()


  • X-ray image interpretive software
  • Diagnostic x-ray digital imaging system workstation
InferRead CT Stroke.AI is a radiological computer aided triage and notification software for use in the analysis of non-enhanced head CT images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging suspected positive findings of intracranial hemorrhage (ICH).
Infervision US Inc
1.1.0.0
In Commercial Distribution

  • 00850003095011 ()


  • Diagnostic x-ray digital imaging system workstation
  • X-ray image interpretive software
Computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during review of CT examinations of the chest.
Infervision US Inc
2.1.2.1
In Commercial Distribution

  • 00850003095004 ()


  • X-ray image interpretive software
  • Diagnostic x-ray digital imaging system workstation
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
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
GORNEY SCISSORS DOUBLE BEVELED POWER CUT GOLD CURVED BLADES QUANTUM
SONTEC INSTRUMENTS, INC.
1200-413Q
In Commercial Distribution

  • 00192896099302 ()

  • Length: 6.75 Inch
1200-413Q

  • Nasal scissors
METZENBAUM SCISSORS LEFT HANDED CURVED BLADE POWER CUT GOLD QUANTUM
SONTEC INSTRUMENTS, INC.
1200-332LQ
In Commercial Distribution

  • 00192896098008 ()

  • Length: 5.75 Inch
1200-332LQ

  • General-purpose surgical scissors, reusable
LISTER BANDAGE SCISSORS LARGE DOUBLE RING POWER CUT GOLD QUANTUM
SONTEC INSTRUMENTS, INC.
1200-210Q
In Commercial Distribution

  • 00192896097292 ()

  • Length: 8 Inch
1200-210Q

  • Bandage scissors, reusable
MAYO HEGAR NEEDLE HOLDER STREAMLINED TUNGSTEN CARBIDE SERRATED TIP QUANTUM
SONTEC INSTRUMENTS, INC.
2300-720Q
In Commercial Distribution

  • 00192896097186 ()

  • Length: 8 Inch
2300-720Q

  • Suturing needle holder, reusable
OLSEN-HEGAR DELUXE NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED 5.75 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1100-106DQ
In Commercial Distribution

  • 00192896095083 ()

  • Length: 5.75 Inch
1100-106DQ

  • Suturing needle holder, reusable
LARYNGOSCOPY FORCEPS UP- ANGLE HEART SHAPED TIP CONICAL TUBE QUANTUM
SONTEC INSTRUMENTS, INC.
1301-260Q
In Commercial Distribution

  • 00192896093713 ()

  • 2 Millimeter Shaft
  • Length: 9 Inch
1301-260Q

  • Flexible endoscopic biopsy forceps, reusable
SONTEC ALLIGATOR FORCEPS EXTRA DELICATE TUNGSTEN CARBIDE SMOOTH TIP QUANTUM
SONTEC INSTRUMENTS, INC.
469-038Q
In Commercial Distribution

  • 00192896092563 ()

  • Length: 3 Inch
  • 0.9 x 4 Millimeters Tip
469-038Q

  • Surgical soft-tissue manipulation forceps, alligator, reusable
DESMARRES CHALAZION CLAMP FORCEPS SOLID LOWER OVAL MEDIUM SIZE QUANTUM
SONTEC INSTRUMENTS, INC.
14-9901Q
In Commercial Distribution

  • 00192896091573 ()

  • Lumen/Inner Diameter: 21 Millimeter
14-9901Q

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
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
WEIL CUT-THROUGH RONGEUR UP-ANGLE TIP SCISSOR ACTION FENESTRATED JAW QUANTUM
SONTEC INSTRUMENTS, INC.
468-654Q
In Commercial Distribution

  • 00192896079946 ()

  • Length: 4.5 Inch
  • 2.5 x 5.5 Millimeter Tip
468-654Q

  • Craniofacial rongeur, reusable
CASTROVIEJO CORNEOSCLERAL SCISSORS SMALL/MEDIUM BLUNT LEFT ANGLED BLADES QUANTUM
SONTEC INSTRUMENTS, INC.
13-1307Q
In Commercial Distribution

  • 00192896072992 ()

  • Length: 4 Inch
  • 10 Millimeter Blades
13-1307Q

  • Corneal scissors, 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
LARYNGOSCOPY FORCEPS STRAIGHT HEART SHAPED TIP CONICAL TUBE SHAFT QUANTUM
SONTEC INSTRUMENTS, INC.
1301-254Q
In Commercial Distribution

  • 00192896099838 ()

  • Length: 9 Inch
  • 1 Millimeter Shaft
1301-254Q

  • Flexible endoscopic biopsy forceps, reusable
WEIL CUT-THROUGH RONGEUR STRAIGHT TIP SCISSOR ACTION FENESTRATED JAW QUANTUM
SONTEC INSTRUMENTS, INC.
468-650Q
In Commercial Distribution

  • 00192896099722 ()

  • Length: 4.5 Inch
  • 2.5 x 5 Millimeter Tip
468-650Q

  • Craniofacial rongeur, reusable
OLSEN-HEGAR DELUXE NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED 6.75 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1100-108DQ
In Commercial Distribution

  • 00192896099364 ()

  • Length: 6.75 Inch


  • Suturing needle holder, reusable
OLSEN WEBSTER NEEDLE HOLDER DELICATE TUNGSTEN CARBIDE SERRATED TIP QUANTUM
SONTEC INSTRUMENTS, INC.
132-359Q
In Commercial Distribution

  • 00192896099357 ()

  • Length: 4.75 Inch


  • Suturing needle holder, reusable
FOSTER GILLIES NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED STRAIGHT TIP QUANTUM
SONTEC INSTRUMENTS, INC.
132-387Q
In Commercial Distribution

  • 00192896099340 ()

  • Length: 3.875 Inch
132-387Q

  • Suturing needle holder, reusable
MAYO HEGAR NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED TIP STREAMLINED QUANTUM
SONTEC INSTRUMENTS, INC.
2300-723Q
In Commercial Distribution

  • 00192896099333 ()

  • Length: 9 Inch
2300-723Q

  • Suturing needle holder, reusable
MICRO ALLIGATOR FORCEPS WITH LOCK DELICATE RIGHT CURVED TIP QUANTUM
SONTEC INSTRUMENTS, INC.
469-050Q
In Commercial Distribution

  • 00192896097360 ()

  • Length: 3 Inch
  • 4 x 0.9 Millimeter Tip
469-050Q

  • Surgical soft-tissue manipulation forceps, alligator, reusable
ECHLIN DUCKBILL RONGEUR DOUBLE ACTION CURVED TO SIDE TIP QUANTUM
SONTEC INSTRUMENTS, INC.
315-661Q
In Commercial Distribution

  • 00192896095182 ()

  • Length: 9 Inch
  • 4 x 12 Millimeter Tip
315-661Q

  • Orthopaedic joint/limb rongeur
ECHLIN DUCKBILL RONGEUR DOUBLE ACTION CURVED TO SIDE TIP QUANTUM
SONTEC INSTRUMENTS, INC.
315-657Q
In Commercial Distribution

  • 00192896095090 ()

  • 3 x 12 Millimeter Tip
  • Length: 9 Inch
315-657Q

  • Orthopaedic joint/limb rongeur
LARYNGOSCOPY FORCEPS RIGHT UP-ANGLE HEART SHAPED TIP CONICAL TUBE QUANTUM
SONTEC INSTRUMENTS, INC.
1301-262Q
In Commercial Distribution

  • 00192896093720 ()

  • 45 Degree Tip
  • Length: 9 Inch
  • 2 Millimeter Shaft
1301-262Q

  • Flexible endoscopic biopsy forceps, reusable
LARYNGOSCOPY FORCEPS CURVED LEFT HEART SHAPED TIP CONICAL TUBE QUANTUM
SONTEC INSTRUMENTS, INC.
1301-258Q
In Commercial Distribution

  • 00192896093706 ()

  • Length: 9 Inch
  • 2 Millimeter Shaft
1301-258Q

  • Flexible endoscopic biopsy forceps, reusable
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