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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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34W X 24D X 11H X 10° Solar™ Trial
DEGEN MEDICAL, INC.
12-04T342411L10
In Commercial Distribution

  • 00842048171638 ()

  • Width (34 Millimeter);Depth (24 Millimeter);Height (11 Millimeter);Lordosis (10 Degrees)
12-04T342411L10

  • Spinal implant trial
34W X 24D X 11H X 0° Solar™ Trial
DEGEN MEDICAL, INC.
12-04T342411L00
In Commercial Distribution

  • 00842048171614 ()

  • Width (34 Millimeter);Depth (24 Millimeter);Height (11 Millimeter);Lordosis (0 Degrees)
12-04T342411L00

  • Spinal implant trial
SUBDURAL GRID ELECTRODE, PLATINUM, 24 CONTACT, 4X6, CONTACT #1 RADIOPAQUE, SMOOTH, INLINE CONNECTOR, 2 TOP EXITS, 2 LEADS, 2 TAILS, TOP & BOTTOM ROWS NUMBERED, PERFORATED HOLES
PMT CORPORATION
2110-24-105-NS
In Commercial Distribution

  • 00650551078234 ()

  • Thickness 0.76 Millimeter
  • Contact Diameter 3 Millimeter
2110-24-105-NS

  • Cortical electrode
107" 15 Drop 24 Hour Primary Set w/2 Bravo24®, 2 Gang 1o2® Manifold w/Check Valve, Rotating Luer, Drop-In Ext w/Bravo24®
ICU MEDICAL, INC.
B59013
In Commercial Distribution

  • 10887709010632 ()
  • 00887709010635 ()


  • Basic intravenous administration set, noninvasive
120" (305 cm) Appx 15.4 ml, 15 Drop 24 Hour Primary Set w/2 Bravo24®, Remv 2 Gang 1o2® Manifold, Rotating Luer, 1 Ext
ICU MEDICAL, INC.
B59004
In Commercial Distribution

  • 10887709010489 ()
  • 00887709010482 ()


  • Basic intravenous administration set, noninvasive
CERTEX 4.0 X 24mm THREADED X 16mm SMOOTH X 40mm OVERALL SMOOTH SHANK SCREW ASSEMBLY
Xtant Medical Holdings, Inc.
X067-1556
Not in Commercial Distribution

  • M697X06715561 ()

  • Length: 24 Millimeter
  • Length: 16 Millimeter
  • Outer Diameter: 4 Millimeter


  • Spinal bone screw, non-bioabsorbable
CERTEX 4.0 X 24mm THREADED X 13mm SMOOTH X 37mm OVERALL SMOOTH SHANK SCREW ASSEMBLY
Xtant Medical Holdings, Inc.
X067-1555
Not in Commercial Distribution

  • M697X06715551 ()

  • Outer Diameter: 4 Millimeter
  • Length: 13 Millimeter
  • Length: 24 Millimeter


  • Spinal bone screw, non-bioabsorbable
CERTEX 4.0 X 24mm THREADED X 10mm SMOOTH X 34mm OVERALL SMOOTH SHANK SCREW ASSEMBLY
Xtant Medical Holdings, Inc.
X067-1554
Not in Commercial Distribution

  • M697X06715541 ()

  • Length: 24 Millimeter
  • Outer Diameter: 4 Millimeter
  • Length: 10 Millimeter


  • Spinal bone screw, non-bioabsorbable
Friedman-Otis Bougie-a-Boule, with 3 (graduated) olive tips on one stem. Mirror finish, stainless steel, precision machined.
GRACE MANUFACTURING, INC.
52020-28
In Commercial Distribution

  • 10801334000844 ()

  • Catheter Gauge: 28 French
  • Catheter Gauge: 26 French
  • Catheter Gauge: 24 French
U420

  • Urethral bougie, reusable
All instruments provided by NGMedical are reusable surgical instruments with the purpose of enabling the implantation of an NGMedical implant. The surgical technique of each implant describes the instruments to be used. The instruments may only be used in direct connection with implants from NGMedical and as described in the respective surgical techniques.
NGMedical GmbH
NGM WAVE Expansion Rod 24 mm
In Commercial Distribution

  • 04251631408673 ()
I303

  • Orthopaedic surgical procedure kit, non-medicated, reusable
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