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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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One Piece Dental Implant 3.0mm diameter and 14mm in length crown and bridge head
Suncoast Dental, Inc
One Piece/3.0 x 14CB
In Commercial Distribution

  • 00083208130144 ()

  • Length: 14 Millimeter
  • One Piece 3.0mm Diameter x 14mm Length CB
  • Outer Diameter: 3 Millimeter
ITO 3.0 x 14mm (CB)

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 3.0mm diameter and 11mm in length crown and bridge head
Suncoast Dental, Inc
One Piece/3.0 x 11CB
In Commercial Distribution

  • 00083208130113 ()

  • One Piece 3.0mm Diameter x 11mm Length CB
  • Outer Diameter: 3 Millimeter
  • Length: 11 Millimeter
ITO 3.0 x 11mm (CB)

  • Screw endosteal dental implant, one-piece
Contents: One Suture Passer XL, one 10/12mm Pilot Guide XL and one 15mm Pilot Guide XL. Distributed under REGARD Brand.
Coopersurgical, Inc.
733776
In Commercial Distribution

  • 20888937027055 ()
  • 60888937027053 ()


  • Laparoscopic wound closure thread
VG BRST TABLE 1.5T 16CH GE450 FUL SET w GRID one patient support assembly, one box of 10 sterilized biopsy grids, one Lateral Array coil Right and Left, one Medial Array coil, one 16Ch interface box, Lateral single loop coil Left and Right, and one medial plug.
Philips Medical Systems Nederland B.V.
989603217111
In Commercial Distribution

  • 00884838119819 ()


  • MRI system coil, radio-frequency
Rotational Excisional Atherectomy System.The Catheter Set includes one Rotarex®S catheter (gauge 8F; length 110 cm), one guidewire (0.018” diameter; 270cm in length), one drape and one collecting bag.
Straub Medical AG
Version 1.0
Not in Commercial Distribution

  • 07640142810605 ()

  • Catheter Working Length: 110 Centimeter
  • Catheter Gauge: 8 French
80239

  • Mechanical atherectomy system catheter/handpiece
Rotational Excisional Atherectomy System.The Catheter Set includes one Rotarex®S catheter (gauge 8F; length 85 cm), one guidewire (0.018” diameter; 220cm in length), one drape and one collecting bag.
Straub Medical AG
Version 1.0
Not in Commercial Distribution

  • 07640142810599 ()

  • Catheter Working Length: 85 Centimeter
  • Catheter Gauge: 8 French
80238

  • Mechanical atherectomy system catheter/handpiece
Rotational Excisional Atherectomy System.The Catheter Set includes one Rotarex®S catheter (gauge 6F; length 110 cm), one guidewire (0.018” diameter; 270cm in length), one drape and one collecting bag.
Straub Medical AG
Version 1.0
Not in Commercial Distribution

  • 07640142810575 ()

  • Catheter Working Length: 110 Centimeter
  • Catheter Gauge: 6 French
80236

  • Mechanical atherectomy system catheter/handpiece
Contains one 10858086006280 Cranial Screws, Case of 10 Boxes of 2 Short + 2 Long; one 00858086006252 Headframe Kit; and one Couch Adapter
VARIAN MEDICAL SYSTEMS, INC.
P1006805006
In Commercial Distribution

  • 00858086006313 ()


  • Stereotactic radiosurgical invasive head frame
Contains: one 12-pack Eclipse Clear Upper Baseplate Resin (905006), one 12-pack Eclipse Clear Lower Baseplate Resin (905012), one 12-pack Eclipse Resilient Resin (906080), one 12-pack Eclipse Original Upper Baseplate Resin (905001), one 12-pack Eclipse Original Lower Baseplate Resin (905007), one Eclipse Wax Remover (905620), one PermaSoft Soft Denture Liner Kit (N811100), and one Eclipse Bonding Agent Kit (905550), along with miscellaneous accessories (non-medical devices)
Dentsply International Inc.
Starter Package with Bonding Agent
Not in Commercial Distribution

  • D0019056450 ()
905645

  • Dental appliance fabrication material, resin
Contains: one 12-pack Eclipse Clear Upper Baseplate Resin (905006), one 12-pack Eclipse Clear Lower Baseplate Resin (905012), one 12-pack Eclipse Resilient Resin (906080), one 12-pack Eclipse Original Upper Baseplate Resin (905001), one 12-pack Eclipse Original Lower Baseplate Resin (905007), one Eclipse Wax Remover (905620), and one PermaSoft Soft Denture Liner Kit (N811100), along with miscellaneous accessories (non-medical devices)
Dentsply International Inc.
Starter Package
Not in Commercial Distribution

  • D0019055850 ()
905585

  • Dental appliance fabrication material, resin
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