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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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TURNER WARWICK NEEDLE HOLDER - 00192896098428

TURNER WARWICK NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED TIP CURVED SHANK OFF SET RING QUANTUM
SONTEC INSTRUMENTS, INC.
132-209LQ
In Commercial Distribution

  • 00192896098428 ()

  • Length: 9.25 Inch
132-209LQ

  • Suturing needle holder, reusable

METZENBAUM SCISSORS - 00192896098046

METZENBAUM SCISSORS CURVED BLUNT TUNGSTEN CARBIDE BLADE POWER CUT GOLD/BLACK SPREAD HANDLE QUANTUM
SONTEC INSTRUMENTS, INC.
1200-526Q
In Commercial Distribution

  • 00192896098046 ()

  • Length: 7 Inch
1200-526Q

  • General-purpose surgical scissors, reusable

TURNER WARWICK NEEDLE HOLDER - 00192896099319

TURNER WARWICK NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED TIP CURVED SHANK OFF SET RINGS QUANTUM
SONTEC INSTRUMENTS, INC.
132-209Q
In Commercial Distribution

  • 00192896099319 ()

  • Length: 8.5 Inch
132-209Q

  • Suturing needle holder, reusable

Echlin Duckbill Rongeur - 00192896108486

Echlin Duckbill Rongeur Double Action Curved To Side 3 Millimeters X 12 Millimeters Quantum
SONTEC INSTRUMENTS, INC.
315-659Q
In Commercial Distribution

  • 00192896108486 ()

  • Length: 9 Inch


  • Orthopaedic joint/limb rongeur

Laryngoscopy Forceps - 00192896107069

LARYNGOSCOPY FORCEPS CONICAL TUBE 1 MILLIMETER SHAFT UP-ANGLE HEART SHAPED 45 DEGREES LEFT QUANTUM
SONTEC INSTRUMENTS, INC.
1301-220Q
In Commercial Distribution

  • 00192896107069 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable

Stefan Miniature Bone Holding Forceps - 00192896121522

Stefan Miniature Bone Holding Forceps With Speed Lock Curved Serrated Jaws 4 Inches Quantum
SONTEC INSTRUMENTS, INC.
1103.003Q
In Commercial Distribution

  • 00192896121522 ()

  • Length: 4 Inch
1103-003Q

  • Bone holding forceps

QUANTUM™ CT Overlay - 10841962111291

GE Gen2 QUANTUM CT Overlay for GE GT 1700 and GE NG2000V CT Scanners
Qfix
RT-4550GER2
In Commercial Distribution

  • 10841962111291 ()

  • Length: 207 Centimeter
RT-4550GER2

  • Indexed-immobilization patient positioning system

Quantum MIS Cannulated System - 00846468050535

Nerve Monitoring Cable
Pioneer Surgical Technology, Inc.
51-STIM-1
Not in Commercial Distribution

  • 00846468050535 ()
51-STIM-1

  • Nerve-function monitor

Quantum Spinal Fixation System - 00846468002671

YOKE FORK
Pioneer Surgical Technology, Inc.
10-YOKEFORK
Not in Commercial Distribution

10-YOKEFORK

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002657

X-LINK BENDER, PERPENDICULAR
Pioneer Surgical Technology, Inc.
10-XLNKBNDRPER
Not in Commercial Distribution

10-XLNKBNDRPER

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002633

WRENCH, X-LINK
Pioneer Surgical Technology, Inc.
10-XLINKWRENCH
Not in Commercial Distribution

10-XLINKWRENCH

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002626

X-LINK GAGE
Pioneer Surgical Technology, Inc.
10-XLINKGAGE
Not in Commercial Distribution

10-XLINKGAGE

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002565

CADDY, X-LINK, VARIABLE
Pioneer Surgical Technology, Inc.
10-VXLCADDY
Not in Commercial Distribution

10-VXLCADDY

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002541

TAP, 7.25mm, EXTENDED LENGTH
Pioneer Surgical Technology, Inc.
10-TAP-725-E
Not in Commercial Distribution

10-TAP-725-E

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002510

TAP, 6.25mm, EXTENDED LENGTH
Pioneer Surgical Technology, Inc.
10-TAP-625-E
Not in Commercial Distribution

10-TAP-625-E

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002442

TAP, 4.25mm
Pioneer Surgical Technology, Inc.
10-TAP-425
Not in Commercial Distribution

10-TAP-425

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002411

SCREW INSERTER
Pioneer Surgical Technology, Inc.
10-SCRWINSERT-S
Not in Commercial Distribution

10-SCRWINSERT-S

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002374

COUNTER TORQUE WRENCH
Pioneer Surgical Technology, Inc.
10-RR-HANDLE
Not in Commercial Distribution

10-RR-HANDLE

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002350

CADDY, ROD, STRAIGHT
Pioneer Surgical Technology, Inc.
10-RODCADDY-RR
Not in Commercial Distribution

10-RODCADDY-RR

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002343

CADDY, ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
10-RODCADDY-PR
Not in Commercial Distribution

10-RODCADDY-PR

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002336

CADDY, ROD
Pioneer Surgical Technology, Inc.
10-RODCADDY
Not in Commercial Distribution

10-RODCADDY

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002329

ROCKER
Pioneer Surgical Technology, Inc.
10-ROCKER
Not in Commercial Distribution

10-ROCKER

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002312

X-LINK REMOVAL WRENCH
Pioneer Surgical Technology, Inc.
10-REMWRENCH
Not in Commercial Distribution

10-REMWRENCH

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002305

RAPID REDUCER
Pioneer Surgical Technology, Inc.
10-RAPIDREDUCR
Not in Commercial Distribution

10-RAPIDREDUCR

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002299

ROD PERSUADER
Pioneer Surgical Technology, Inc.
10-PERSUADER
Not in Commercial Distribution

10-PERSUADER

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002282

CADDY, SCREW, POLYAXIAL 7.75mm
Pioneer Surgical Technology, Inc.
10-PACADDY-775
Not in Commercial Distribution

10-PACADDY-775

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002275

CADDY, SCREW, POLYAXIAL 6.75mm
Pioneer Surgical Technology, Inc.
10-PACADDY-675
Not in Commercial Distribution

10-PACADDY-675

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002268

CADDY, SCREW, POLYAXIAL 5.75mm
Pioneer Surgical Technology, Inc.
10-PACADDY-575
Not in Commercial Distribution

10-PACADDY-575

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002251

CADDY, SCREW, POLYAXIAL 4.75mm
Pioneer Surgical Technology, Inc.
10-PACADDY-475
Not in Commercial Distribution

10-PACADDY-475

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002237

CADDY, ILIAC BOLT, POLYAXIAL
Pioneer Surgical Technology, Inc.
10-PABCADDY-775
Not in Commercial Distribution


  • 7.75mm
10-PABCADDY-775

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002213

OSTEOTOME
Pioneer Surgical Technology, Inc.
10-OSTEOTOME
Not in Commercial Distribution

10-OSTEOTOME

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002190

ROD REDUCER, ANGLED
Pioneer Surgical Technology, Inc.
10-MANIPANGLED
Not in Commercial Distribution

10-MANIPANGLED

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002152

INSTRUMENT CASE, LUMBAR, SECONDARY
Pioneer Surgical Technology, Inc.
10-INSTCASE-S
Not in Commercial Distribution

10-INSTCASE-S

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002138

INSTRUMENT CASE
Pioneer Surgical Technology, Inc.
10-INSTCASE
Not in Commercial Distribution

10-INSTCASE

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002091

IMPLANT CASE, THORACOLUMBAR
Pioneer Surgical Technology, Inc.
10-IMPCASE-TL
Not in Commercial Distribution

10-IMPCASE-TL

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002077

HOOK PUSHER
Pioneer Surgical Technology, Inc.
10-HOOKPUSHER
Not in Commercial Distribution

10-HOOKPUSHER

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002046

GOUGE
Pioneer Surgical Technology, Inc.
10-GOUGE
Not in Commercial Distribution

10-GOUGE

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002022

CADDY, X-LINK, FIXED
Pioneer Surgical Technology, Inc.
10-FXLCADDY
Not in Commercial Distribution

10-FXLCADDY

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002008

FIXED, ILIAC BOLT CADDY
Pioneer Surgical Technology, Inc.
10-FXBCADDY-875
Not in Commercial Distribution


  • 8.75mm
10-FXBCADDY-875

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001971

ELEVATOR, LAMINA
Pioneer Surgical Technology, Inc.
10-ELEVATOR-L
Not in Commercial Distribution

10-ELEVATOR-L

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001964

CLAW ROD PUSHER
Pioneer Surgical Technology, Inc.
10-CLAWPUSHER
Not in Commercial Distribution

10-CLAWPUSHER

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001957

CAP LOCKER, LONG
Pioneer Surgical Technology, Inc.
10-CAPLOCKER-L
Not in Commercial Distribution

10-CAPLOCKER-L

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001940

CAP INSERTER, LONG
Pioneer Surgical Technology, Inc.
10-CAPINSRTR-L
Not in Commercial Distribution

10-CAPINSRTR-L

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001933

INITIAL INSERTER
Pioneer Surgical Technology, Inc.
10-CAPINSERTER
Not in Commercial Distribution

10-CAPINSERTER

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001926

CADDY, LATERAL OFFSET CONNECTOR
Pioneer Surgical Technology, Inc.
10-CADDY-LOC
Not in Commercial Distribution

10-CADDY-LOC

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001919

CADDY, HOOK
Pioneer Surgical Technology, Inc.
10-CADDY-HOOKS
Not in Commercial Distribution

10-CADDY-HOOKS

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001902

CADDY, AUXILIARY SCREW
Pioneer Surgical Technology, Inc.
10-CADDY-AUX
Not in Commercial Distribution

10-CADDY-AUX

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001896

CORONAL BENDER, RIGHT
Pioneer Surgical Technology, Inc.
10-BENDER-C-R
Not in Commercial Distribution

10-BENDER-C-R

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001889

CORONAL BENDER, LEFT
Pioneer Surgical Technology, Inc.
10-BENDER-C-L
Not in Commercial Distribution

10-BENDER-C-L

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001872

BONE AWL
Pioneer Surgical Technology, Inc.
10-AWL-10-30
Not in Commercial Distribution


  • 10mm-30mm
10-AWL-10-30

  • General internal orthopaedic fixation system implantation kit
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