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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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Valeo Spacer System - M555110072040

Valeo Rod, ø5.5mm x 40mm, Curved
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555110072040 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 40 Millimeter
11.007.2040

  • Bone-screw internal spinal fixation system rod

Valeo Spacer System - M555110043615

Valeo PL,9x25, 6°, 15mm
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555110043615 ()

  • Height: 15 Millimeter
  • Width: 25 Millimeter
  • Length: 9 Millimeter
11.004.3615

  • Vertebral body prosthesis

Valeo Spacer System - M555110043614

Valeo PL,9x25, 6°, 14mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555110043614 ()

  • Length: 9 Millimeter
  • Width: 25 Millimeter
  • Height: 14 Millimeter
11.004.3614

  • Ceramic spinal interbody fusion cage

Valeo Spacer System - M555110043613

Valeo PL,9x25, 6°, 13mm
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555110043613 ()

  • Height: 13 Millimeter
  • Width: 25 Millimeter
  • Length: 9 Millimeter
11.004.3613

  • Vertebral body prosthesis

Valeo Spacer System - M555110043612

Valeo PL,9x25, 6°, 12mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555110043612 ()

  • Length: 9 Millimeter
  • Width: 25 Millimeter
  • Height: 12 Millimeter
11.004.3612

  • Ceramic spinal interbody fusion cage

Valeo Spacer System - M555110043611

Valeo PL,9x25, 6°, 11mm
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555110043611 ()

  • Height: 11 Millimeter
  • Width: 25 Millimeter
  • Length: 9 Millimeter
11.004.3611

  • Vertebral body prosthesis

Valeo Spacer System - M555110043610

Valeo PL,9x25, 6°, 10mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555110043610 ()

  • Length: 9 Millimeter
  • Width: 25 Millimeter
  • Height: 10 Millimeter
11.004.3610

  • Ceramic spinal interbody fusion cage

Valeo Spacer System - M555110043609

Valeo PL,9x25, 6°, 9mm
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555110043609 ()

  • Height: 9 Millimeter
  • Width: 25 Millimeter
  • Length: 9 Millimeter
11.004.3609

  • Vertebral body prosthesis

Valeo Spacer System - M555110043608

Valeo PL,9x25, 6°, 8mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555110043608 ()

  • Length: 9 Millimeter
  • Width: 25 Millimeter
  • Height: 8 Millimeter
11.004.3608

  • Ceramic spinal interbody fusion cage

Valeo Spacer System - M555110043607

Valeo PL,9x25, 6°, 7mm
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555110043607 ()

  • Height: 7 Millimeter
  • Width: 25 Millimeter
  • Length: 9 Millimeter
11.004.3607

  • Vertebral body prosthesis

Valeo Spacer System - M555110041615

Valeo PL,9x21, 6°, 15mm
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555110041615 ()

  • Height: 15 Millimeter
  • Width: 21 Millimeter
  • Length: 9 Millimeter
11.004.1615

  • Vertebral body prosthesis

Valeo Spacer System - M555110041614

Valeo PL,9x21, 6°, 14mm
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555110041614 ()

  • Length: 9 Millimeter
  • Width: 21 Millimeter
  • Height: 14 Millimeter
11.004.1614

  • Vertebral body prosthesis

Valeo Spacer System - M555110041613

Valeo PL,9x21, 6°, 13mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555110041613 ()

  • Height: 13 Millimeter
  • Width: 21 Millimeter
  • Length: 9 Millimeter
11.004.1613

  • Ceramic spinal interbody fusion cage

Valeo Spacer System - M555110041612

Valeo PL,9x21, 6°, 12mm
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555110041612 ()

  • Length: 9 Millimeter
  • Width: 21 Millimeter
  • Height: 12 Millimeter
11.004.1612

  • Vertebral body prosthesis

Valeo Spacer System - M555110041611

Valeo PL,9x21, 6°, 11mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555110041611 ()

  • Height: 11 Millimeter
  • Width: 21 Millimeter
  • Length: 9 Millimeter
11.004.1611

  • Ceramic spinal interbody fusion cage

Valeo Fusion System - M555110041610

Valeo PL,9x21, 6°, 10mm
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555110041610 ()

  • Length: 9 Millimeter
  • Width: 21 Millimeter
  • Height: 10 Millimeter
11.004.1610

  • Vertebral body prosthesis

Valeo Fusion System - M555110041609

Valeo PL,9x21, 6°, 9mm
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555110041609 ()

  • Height: 9 Millimeter
  • Width: 21 Millimeter
  • Length: 9 Millimeter
11.004.1609

  • Vertebral body prosthesis

Valeo Fusion System - M555110041608

Valeo PL,9x21, 6°, 8mm
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555110041608 ()

  • Height: 8 Millimeter
  • Width: 21 Millimeter
  • Length: 9 Millimeter
11.004.1608

  • Vertebral body prosthesis

Valeo Fusion System - M555110041607

Valeo PL,9x21, 6°, 7mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555110041607 ()

  • Length: 9 Millimeter
  • Width: 21 Millimeter
  • Height: 7 Millimeter
11.004.1607

  • Ceramic spinal interbody fusion cage

Preference 2 - M555102961536

36mm Fixed Cross Connector Assembly
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555102961536 ()

  • Length: 36 Millimeter
10-2961-536

  • Bone-screw internal spinal fixation system connector

Preference 2 - M555102961518

18mm Fixed Cross Connector Assembly
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555102961518 ()

  • Length: 18 Millimeter
10-2961-518

  • Bone-screw internal spinal fixation system connector

Taurus Pedicle Screw System - M555502000006

Probe, Lenke, Straight
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555502000006 ()
50-2000-006

  • Internal spinal fixation procedure kit, reusable

Taurus Pedicle Screw System - M555502000005

Probe, Lenke, Curved
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555502000005 ()
50-2000-005

  • Internal spinal fixation procedure kit, reusable

Taurus Pedicle Screw System - M555502000003

Probe, Pedicle, Curved, Duckbill
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555502000003 ()
50-2000-003

  • Internal spinal fixation procedure kit, reusable

Taurus Pedicle Screw System - M555502000002

Probe, Sounder, Straight
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555502000002 ()
50-2000-002

  • Internal spinal fixation procedure kit, reusable

Taurus Pedicle Screw System - M555501000002

K-Wire - Nitinol
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555501000002 ()
50-1000-002

  • Internal spinal fixation procedure kit, reusable

Taurus Pedicle Screw System - M555500000104

Taurus Case 2 - Base
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555500000104 ()
50-0000-104

  • Instrument tray, reusable

Shoveler MS 20° Left - 10818674022269

No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10818674022269 ()
743221t

  • Cast cutting shears

Shoveler MS 20° Right - 10818674022252

No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10818674022252 ()
743211

  • Cast cutting shears

Shoveler MS Straight - 10818674022245

No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10818674022245 ()
743200

  • Cast cutting shears

Shoveler WR 15° Up - 10818674022238

No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10818674022238 ()
733231t

  • Cast cutting shears

High Density Junction Box - B - 00850011306383

Passive adapter with touchproof inputs and a high density output for adapting 3rd party electrode interface cables to the ATLAS Neurophysiology System. Version "B" is labeled for connections to electrodes 65-128.
NEURALYNX, INC.
-B
In Commercial Distribution

  • 00850011306383 ()
31-0602-0034

  • Electrical-only medical device connection cable, reusable

SuperBall - 00850000630017

The SuperBall Meniscal Repair System is a single patient, single use, an all-inside, all-suture meniscal repair device.
ARCURO MEDICAL LTD
B
In Commercial Distribution

  • 00850000630017 ()
SBD-SB-12-001

  • Polyester suture, non-bioabsorbable, multifilament

Lara Docking Station - 00850014578107

No Description
LUCERNO DYNAMICS, LLC
B
In Commercial Distribution

  • 00850014578251 ()
  • 00850014578107 ()
401874-285

  • Scintillation-counter radiation survey meter

Lara Reader - 00850014578008

No Description
LUCERNO DYNAMICS, LLC
B
In Commercial Distribution

  • 00850014578169 ()
  • 00850014578008 ()
401874-230

  • Scintillation-counter radiation survey meter

Adept Medical Drape Support - 09421905187589

To support drape over patient face
ADEPT MEDICAL LIMITED
B
In Commercial Distribution

  • 09421905187589 ()
AM1000B

  • Radiological arm/leg positioner

Adept Medical STARBoard and Extension Tray - 09421905187572

Support patient arm
ADEPT MEDICAL LIMITED
B
In Commercial Distribution

  • 09421905187572 ()
AM0180

  • Radiological arm/leg positioner

Adept Medical Drape Support - 09421905187411

To support the sterile drape over the patient.
ADEPT MEDICAL LIMITED
B
In Commercial Distribution

  • 09421905187411 ()
AM1000B

  • Bedding support

Macy Catheter Tray - 00861003000226

Convenience tray for the Macy Catheter. Contents include: Macy Catheter, 60ml Enteral/Oral Syringe, 10ml Enteral/Oral Syringe, 3ml Enteral/Oral Syringe, (2) 10ml Pre-filled Balloon Inflation Syringes, Macy Catheter Instructions for Use, 3-Ply Poly Towel, Nitrile Gloves, Lubricating Jelly, Catheter Securing Device.
HOSPI CORPORATION
B
In Commercial Distribution

  • 00861003000226 ()
  • 10861003000223 ()
MCT-1001

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

A/M Guide - LEFT ACL, 5mm - 10810190016050

No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190016050 ()
tg108022fst

  • Ligament reconstruction instrument set, reusable
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