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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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BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite enamel shells for direct veneering. BRILLIANT COMPONEER Set upper jaw premolars Bleach Translucent S 14 /24
Coltène/Whaledent AG
60023194
In Commercial Distribution

  • J00660023194 ()
60023194

  • Dental veneer, professional
Monoart Istant Ice guaratees better quality and longer lasting cooling. Disposable bag made of K2P-cellulosa. Shelf life: 5 years. Size 150x175 mm. Carton of 24 bags.
EURONDA SPA
MONOART INSTANT ICE
In Commercial Distribution

  • E307232300200 ()
23230020

  • Hot/cold therapy pack, single-use
TENURE MPB SYSTEM BAG
DEN-MAT HOLDINGS, LLC
039811401
In Commercial Distribution

  • D8130398114010 ()
039811401

  • Dentine bonding agent/set
The mini Kompressor Compression Screw is a two-piece fixation device intended for the use in the reduction, stabilization, and internal fixation of bone fractures. The 2-piece design incorporates the use of a leading and trailing screw component. The implant utilizes a variance in thread pitch between the leading and trailing portions of the screw to reduce and fix fracture fragments, and is available in a variety of sizes to accommodate various fracture types and sites.
Ascension Orthopedics, Inc.
210324
Not in Commercial Distribution

  • M2482103241 ()
  • 10381780065760 ()

  • 3.6 mm dia x 28 mm L; leading screw 24 mm L
210324

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The mini Kompressor Compression Screw is a two-piece fixation device intended for the use in the reduction, stabilization, and internal fixation of bone fractures. The 2-piece design incorporates the use of a leading and trailing screw component. The implant utilizes a variance in thread pitch between the leading and trailing portions of the screw to reduce and fix fracture fragments, and is available in a variety of sizes to accommodate various fracture types and sites.
Ascension Orthopedics, Inc.
210320
Not in Commercial Distribution

  • M2482103201 ()
  • 10381780065746 ()

  • 3.6 mm dia x 24 mm L; leading screw 20 mm L
210320

  • Orthopaedic bone screw, non-bioabsorbable, sterile
STRETCH VASC GRAFT SW BIFUR 24-12mmX40cm
W. L. Gore & Associates, Inc.
SB2401D
In Commercial Distribution

  • H373SB2401D34 ()
  • 00733132611904 ()

  • Lumen/Inner Diameter: 12 Millimeter
  • Length: 40 Centimeter
  • Lumen/Inner Diameter: 24 Millimeter
SB2401D

  • Synthetic vascular graft
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
AngioVac Cannula
NAVILYST MEDICAL, INC.
25184
Not in Commercial Distribution

  • H965251840 ()

  • Catheter Gauge: 22 French
  • Outer Diameter: 24 Millimeter
  • Length: 80 Centimeter


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
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