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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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Quantum Spinal Fixation System - 00846468002572

GAGE, X-LINK, VARIABLE, 30mm-40mm
Pioneer Surgical Technology, Inc.
10-VXLG-3040
Not in Commercial Distribution

10-VXLG-3040

  • 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 - 00846468002527

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

10-TAP-725

  • 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 - 00846468002473

TAP, 5.25mm, 1" THREAD
Pioneer Surgical Technology, Inc.
10-TAP-525-1
Not in Commercial Distribution

10-TAP-525-1

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002459

TAP, 4.25mm, 1" THREAD
Pioneer Surgical Technology, Inc.
10-TAP-425-1
Not in Commercial Distribution

10-TAP-425-1

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002435

TAP, 3.5mm
Pioneer Surgical Technology, Inc.
10-TAP-350
Not in Commercial Distribution

10-TAP-350

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002404

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

10-SCRWINSERT

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002381

SCREW GAGE
Pioneer Surgical Technology, Inc.
10-SCREWGAGE
Not in Commercial Distribution

10-SCREWGAGE

  • 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 - 00846468002367

ROD FORCEPS, 25°, Ø 5.5mm
Pioneer Surgical Technology, Inc.
10-RODFORCEP-25
Not in Commercial Distribution

10-RODFORCEP-25

  • 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 - 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 - 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 - 00846468002244

CADDY, SCREW, POLYAXIAL 4.00mm
Pioneer Surgical Technology, Inc.
10-PACADDY-400
Not in Commercial Distribution

10-PACADDY-400

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002220

CADDY, ILIAC BOLT, POLYAXIAL
Pioneer Surgical Technology, Inc.
10-PABCADDY-675
Not in Commercial Distribution


  • 6.75mm
10-PABCADDY-675

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002206

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

10-MANIPULATOR

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002183

LOCKING TUBE
Pioneer Surgical Technology, Inc.
10-LOCKINGTUBE
Not in Commercial Distribution

10-LOCKINGTUBE

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002060

HOOK HOLDER, ANGLED
Pioneer Surgical Technology, Inc.
10-HOOKHOLDER-A
Not in Commercial Distribution

10-HOOKHOLDER-A

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002053

HOOK HOLDER
Pioneer Surgical Technology, Inc.
10-HOOKHOLDER
Not in Commercial Distribution

10-HOOKHOLDER

  • 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 - 00846468002039

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

10-FXLGAGE

  • 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 - 00846468002015

CADDY, FIXED SCREW
Pioneer Surgical Technology, Inc.
10-FXCADDY-400
Not in Commercial Distribution


  • 4.00mm
10-FXCADDY-400

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001995

FINAL DRIVER
Pioneer Surgical Technology, Inc.
10-FINALDRIVER
Not in Commercial Distribution

10-FINALDRIVER

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001988

ELEVATOR, PEDICLE
Pioneer Surgical Technology, Inc.
10-ELEVATOR-P
Not in Commercial Distribution

10-ELEVATOR-P

  • 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 - 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 - 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 Blue® Reader - EBUHBIPOCTRABS0

No Description
Bühlmann Laboratories AG
BI-POCTR-ABS
Not in Commercial Distribution

  • EBUHBIPOCTRABS0 ()


  • Photometric/spectroscopic immunoassay analyser IVD

Accumax Quantum™ Surface - 00887761017030

Hospital Bed Surface
HILL-ROM, INC.
PCU4
In Commercial Distribution

  • 00887761017030 ()


  • Alternating-pressure inflator

Accumax Quantum™Surface - 00887761001183

Hospital Bed Surface
HILL-ROM, INC.
PCU2
In Commercial Distribution

  • 00887761001183 ()


  • Alternating-pressure inflator
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