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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C Rasp 16x12, 5mm, 0 Deg Stop
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910024006 ()
91.002.4006

  • Internal spinal fixation procedure kit, reusable
16x12 Valeo-C Packing Fixture
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910024002 ()
91.002.4002

  • Orthopaedic implant impactor, reusable
Trial 17x14, 0°, 8mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910023308 ()

  • Length: 17 Millimeter
  • Width: 14 Millimeter
  • Height: 8 Millimeter
91.002.3308

  • Spinal implant trial
Aesculap Container - Valeo C 4 inch
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910021013 ()
91.002.1013

  • Internal spinal fixation procedure kit, reusable
Universal Drill Guide
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910021002 ()
91.002.1002

  • Internal spinal fixation procedure kit, reusable
Distraction Screw - Drill
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910021001 ()
91.002.1001

  • Internal spinal fixation procedure kit, reusable
Valeo TL Trial Full Size, 17mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013517 ()
91.001.3517

  • Spinal implant trial
Valeo TL Trial Full Size, 16mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013516 ()
91.001.3516

  • Spinal implant trial
Valeo TL Trial Full Size, 15mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013515 ()
91.001.3515

  • Spinal implant trial
Valeo TL Trial Full Size, 14mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013514 ()
91.001.3514

  • Spinal implant trial
Valeo TL Trial Full Size, 13mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013513 ()
91.001.3513

  • Spinal implant trial
Valeo TL Trial Full Size, 12mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013512 ()
91.001.3512

  • Spinal implant trial
Valeo TL Trial Full Size, 11mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013511 ()
91.001.3511

  • Spinal implant trial
Valeo TL Trial Full Size, 10mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013510 ()
91.001.3510

  • Spinal implant trial
Valeo TL Trial Full Size, 9mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013509 ()
91.001.3509

  • Spinal implant trial
Valeo TL Trial Full Size, 8mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013508 ()
91.001.3508

  • Spinal implant trial
Valeo TL Trial Full Size, 7mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013507 ()
91.001.3507

  • Spinal implant trial
Valeo TL Implant Trial, 17mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013317 ()
91.001.3317

  • Spinal implant trial
Valeo TL Implant Trial, 15mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013315 ()
91.001.3315

  • Spinal implant trial
Valeo TL Implant Trial, 13mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013313 ()
91.001.3313

  • Spinal implant trial
Valeo TL Implant Trial, 11mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013311 ()
91.001.3311

  • Spinal implant trial
Valeo TL Implant Trial, 9mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013309 ()
91.001.3309

  • Spinal implant trial
Valeo TL Implant Trial, 7mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013307 ()
91.001.3307

  • Spinal implant trial
Nerve Root Retractor, 14mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910012005 ()
91.001.2005

  • Internal spinal fixation procedure kit, reusable
Nerve Root Retractor, 6mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910012004 ()
91.001.2004

  • Internal spinal fixation procedure kit, reusable
Osteotome Straight, 12
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910011012 ()
91.001.1012

  • Internal spinal fixation procedure kit, reusable
Valeo TL, System Catalog Number Tag
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910010024 ()
91.001.0024

  • Instrument tray, reusable
Valeo TL, System Name Tag
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910010023 ()
91.001.0023

  • Instrument tray, reusable
Valeo II Universal Tray Lid
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910009009 ()
91.000.9009

  • Instrument tray, reusable
Valeo II Prep Case Assembly
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910009002 ()
91.000.9002

  • Instrument tray, reusable
Case / Tray Assembly
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910009000 ()
91.000.9000

  • Instrument tray, reusable
1/4 Square Threaded Extender
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910001303 ()
91.000.1303

  • Internal spinal fixation procedure kit, reusable
Slap Hammer Extension
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910001220 ()
91.000.1220

  • Internal spinal fixation procedure kit, reusable
Valeo TL/PL Disc Prep, Aesculap Container and Lid Assembly
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910000025 ()
91.000.0025

  • Instrument tray, reusable
Valeo TL/PL Disc Prep, System Catalog Number Tag
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910000024 ()
91.000.0024

  • Instrument tray, reusable
Valeo TL/PL Disc Prep, System Name Tag
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910000023 ()
91.000.0023

  • Instrument tray, reusable
Valeo C Tray Lid
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910000013 ()
91.000.0013

  • Instrument tray, reusable
Final Tightening Driver
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555507000003 ()
50-7000-003

  • Internal spinal fixation procedure kit, reusable
Posterior Retractor
Revelation Medical Devices
A
In Commercial Distribution

  • G318108260 ()
10-826

  • Hand-held surgical retractor, reusable
XL Suction Stylet
Revelation Medical Devices
A
In Commercial Distribution

  • G31810772530 ()
10-772-53

  • Surgical irrigation/aspiration cannula, non-illuminating, reusable
Large Mallet
Revelation Medical Devices
A
In Commercial Distribution

  • G318101096200 ()
10-1096-20

  • Surgical mallet
1 Lb Mallet
Revelation Medical Devices
A
In Commercial Distribution

  • G318101096100 ()
10-1096-10

  • Surgical mallet
Tangible Boost is a monthly treatment to restore the Tangible Hydra-PEG® coating, and maintain the wettability of Tangible Hydra-PEG coated fluorosilicone acrylate rigid gas permeable lenses. Tangible Boost is intended for prescription (Rx) use only.
TANGIBLE SCIENCE, LLC
A
In Commercial Distribution

  • B673FG6 ()
FG6

  • Contact lens rinsing solution
A 3oz sample bottle of Tangible Clean, a multipurpose cleaner for gas permeable contact lenses and approved for use with Tangible Hydra-PEG.
TANGIBLE SCIENCE, LLC
A
In Commercial Distribution

  • B673FG08600 ()
FG0860

  • Multi-purpose rigid contact lens solution
  • Multi-purpose soft/rigid contact lens solution
A 3 bottle package of Tangible Clean; a multipurpose contact lens solution for gas permeable lenses that is approved for use with Tangible Hydra-PEG.
TANGIBLE SCIENCE, LLC
A
In Commercial Distribution

  • B673FG08233 ()
FG0823

  • Multi-purpose rigid contact lens solution
  • Multi-purpose soft/rigid contact lens solution
Tangible Clean is a multipurpose contact lens cleaner designed for use with gas permeable contact lenses, and is compatible for use with Tangible Hydra-PEG.
TANGIBLE SCIENCE, LLC
A
In Commercial Distribution

  • B673FG08230 ()
FG0823

  • Multi-purpose soft/rigid contact lens solution
  • Multi-purpose rigid contact lens solution
Persuader
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809263399843 ()
FX.IN.0061

  • Bone-screw internal spinal fixation system, non-sterile
Caliper, Ball Tip, 15-210mm
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809263399836 ()
LT.IN.0031

  • Bone-screw internal spinal fixation system, non-sterile
Awl - Cannulated
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809263399744 ()
SI.MI.0120

  • Bone-screw internal spinal fixation system, non-sterile
Poly Screw Driver (Cannulated)
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809263399591 ()
FX.IN.0025

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