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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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The ATHLET VBR System is a lordotic, modular vertebral body replacement system. Caudal and cranial components are offered in a variety of heights and are assembled to create a device construct. An intermediate component is also available and is used between one caudal and one cranial component. The device construct comprises a central cannula for bone graft and lateral fenestrations for bony in-growth.
SIGNUS Medizintechnik GmbH
Main body 9
In Commercial Distribution

  • 04047844002407 ()

  • 42x14x15mm
AT0942

  • Vertebral body prosthesis
No Description
FGX INTERNATIONAL INC.
DL4732/9.FTG
In Commercial Distribution

  • 00193033007280 ()


  • Tinted non-prescription spectacles
A surgical tool intended for discectomy and eroding of the lumbar cage endplate. Once rotated, the Shaver width also enables estimation of the intervertebral space height.
CARBOFIX ORTHOPEDICS LTD
Shaver – 9 mm
In Commercial Distribution

  • 07290110206437 ()
CCLC9009

  • Bone curette, reusable
For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematology instruments. Boule Con-Diff Hematology Control is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific Boule reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
9 x 4.5mL
In Commercial Distribution

  • 00812137010230 ()
  • 00812137011800 ()
501-607

  • Full blood count IVD, control
Scanbody 3D-Guide®
NT-Trading GmbH & Co. KG
TA 9.S33D3.745
In Commercial Distribution

  • ENTTTA9S3D3745 ()

  • Outer Diameter: 3.7 Millimeter
  • Outer Diameter: 4.0 Millimeter
  • Outer Diameter: 4.5 Millimeter
  • Outer Diameter: 5.0 Millimeter
  • Outer Diameter: 6.0 Millimeter
  • Outer Diameter: 7.0 Millimeter
  • Outer Diameter: 8.0 Millimeter


  • Dental implant abutment analog, intraoral-scanning, single-use
No Description
FGX INTERNATIONAL INC.
DL4033/9.FTG
In Commercial Distribution

  • 00887661217653 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
DL4719/9.FTG
In Commercial Distribution

  • 00887661635082 ()


  • Tinted non-prescription spectacles
No Description
Integration Diagnostics Sweden AB
MulTipeg™ 9
In Commercial Distribution

  • 07350096321194 ()
55019

  • Multimeter
Paper Surgical Tape with Dispenser 1"x10 Yards
Avaline Medical NJ Limited Liability Company
1in+DIP +9
In Commercial Distribution

  • 00810124536329 ()
  • 00810124536282 ()


  • Multi-purpose surgical skin adhesive tape
Paper Surgical Tape with Dispenser 2"x10 Yards
Avaline Medical NJ Limited Liability Company
2in+DIP +9
In Commercial Distribution

  • 00810124536336 ()
  • 00810124535933 ()


  • Multi-purpose surgical skin adhesive tape
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