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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No Description
G21 SRL
AR-902-1042M
In Commercial Distribution

  • 08058964728777 ()


  • Orthopaedic cement spacer mould
No Description
G21 SRL
AR-902-0842M
In Commercial Distribution

  • 08058964728661 ()


  • Orthopaedic cement spacer mould
The SpaceFlex Acetabular Cup consists of disposable cement spacer molds indicated for use to mold a temporary Acetabular cup replacement for skeletally mature patients undergoing a two-stage procedure due to a septic process. The temporary prosthesis is molded using low viscosity antibiotic polymethylmethacrylate bone cement (G3A 40 bone cement) and positioned into the acetabular cavity following removal of the existing acetabular and femoral components and radical debridement. The molded acetabular cup is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The molded temporary Acetabular cup prosthesis is indicated for an implantation period of 180 days or less. Because of inherent mechanical limitations of the device material (Bone Cement), the molded temporary prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers) throughout the implant period.
G21 SRL
900203
In Commercial Distribution

  • 08058964727923 ()


  • Orthopaedic cement spacer mould
Large 52A/P x 81M/L Tibial Spacer Mold
Ortho Development Corporation
669-2081
In Commercial Distribution

  • 00822409007608 ()

  • Length: 52 Millimeter
  • Width: 81 Millimeter


  • Orthopaedic cement spacer mould
Medium 45A/P x 70M/L Tibial Spacer Mold
Ortho Development Corporation
669-2070
In Commercial Distribution

  • 00822409007592 ()

  • Width: 70 Millimeter
  • Length: 45 Millimeter


  • Orthopaedic cement spacer mould
Small 39A/P x 58M/L Tibial Spacer Mold
Ortho Development Corporation
669-2058
In Commercial Distribution

  • 00822409007585 ()

  • Width: 58 Millimeter
  • Length: 39 Millimeter


  • Orthopaedic cement spacer mould
Large 53A/P x 75M/L Femoral Spacer Mold
Ortho Development Corporation
669-1075
In Commercial Distribution

  • 00822409007578 ()

  • Width: 75 Millimeter
  • Length: 53 Millimeter


  • Orthopaedic cement spacer mould
Medium 44A/P x 67M/L Femoral Spacer Mold
Ortho Development Corporation
669-1067
In Commercial Distribution

  • 00822409007561 ()

  • Width: 67 Millimeter
  • Length: 44 Millimeter


  • Orthopaedic cement spacer mould
Small 37A/P x 60M/L Femoral Spacer Mold
Ortho Development Corporation
669-1060
In Commercial Distribution

  • 00822409007554 ()

  • Length: 37 Millimeter
  • Width: 60 Millimeter


  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
433180
In Commercial Distribution

  • 00887868543302 ()

  • M/L 80mm A/P 48mm
433180

  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
433175
In Commercial Distribution

  • 00887868543296 ()

  • M/L 75mm A/P 45mm
433175

  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
433170
In Commercial Distribution

  • 00887868543289 ()

  • M/L 70mm A/P 42mm
433170

  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
433165
In Commercial Distribution

  • 00887868543272 ()

  • M/L 65mm A/P 39mm
433165

  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
432175
In Commercial Distribution

  • 00887868543265 ()

  • M/L 75mm A/P 57mm
432175

  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
432170
In Commercial Distribution

  • 00887868543258 ()

  • M/L 70mm A/P 52mm
432170

  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
432165
In Commercial Distribution

  • 00887868543241 ()

  • M/L 65mm A/P 48mm
432165

  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
432160
In Commercial Distribution

  • 00887868543234 ()

  • M/L 60mm A/P 43mm
432160

  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
431414
In Commercial Distribution

  • 00887868543227 ()

  • Ø14mm Stem Ø64mm Head 58mm Head Width 24mm Head Thickness
431414

  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
431412
In Commercial Distribution

  • 00887868543210 ()

  • Ø12mm Stem Ø64mm Head 54mm Head Width 21mm Head Thickness
431412

  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
431410
In Commercial Distribution

  • 00887868543203 ()

  • Ø10mm Stem Ø57mm Head 50mm Head Width 21mm Head Thickness
431410

  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
431408
In Commercial Distribution

  • 00887868543197 ()

  • Ø8mm Stem Ø53mm Head 46mm Head Width 18mm Head Thickness
431408

  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
431406
In Commercial Distribution

  • 00887868543180 ()

  • Ø6mm Stem Ø46mm Head 42mm Head Width 18mm Head Thickness
431406

  • Orthopaedic cement spacer mould
The Putty Convenience Kit (PCK) is a flexible polymer mat with cavities that allows the physician to mold bone putty into beads.
BERKELEY ADVANCED BIOMATERIALS, LLC
ZS9213K-10
In Commercial Distribution

  • 00816125026142 ()
ZS9213K-10

  • Orthopaedic cement spacer mould
The CemSyntek Putty Convenience Kit (PCK) is a flexible polymer mat with cavities that allows the physician to mold bone putty into beads.
BERKELEY ADVANCED BIOMATERIALS, LLC
ZS9213K-5
In Commercial Distribution

  • 00816125026135 ()
ZS9213K-5

  • Orthopaedic cement spacer mould
The CemSyntek Putty Convenience Kit (PCK) is a flexible polymer mat with cavities that allows the physician to mold bone putty into beads.
BERKELEY ADVANCED BIOMATERIALS, LLC
ZS9213K-2
In Commercial Distribution

  • 00816125026128 ()
ZS9213K-2

  • Orthopaedic cement spacer mould
The Putty Convenience Kit (PCK) is a flexible polymer mat with cavities that allows the physician to mold bone putty into beads.
BERKELEY ADVANCED BIOMATERIALS, LLC
PCK-02
In Commercial Distribution

  • 00816125024353 ()
PCK-02

  • Orthopaedic cement spacer mould
Hand shape TENS/EMS Electrode Pads includes specification of 25*50, 46*75, 50*78, 55*80, 64*78, 72*90.
Dong Guan Ou Kang Electronics CO.,LTD
Hand shape
In Commercial Distribution

  • 06976378040044 ()


  • Transcutaneous electrical stimulation electrode, single-use
KS SHAPE
COLTENE/WHALEDENT INC
RLKS1SC012FG
In Commercial Distribution

  • D661RLKS1SC012FG1 ()
  • D661RLKS1SC012FG0 ()


  • Dental abrasive point, reusable
KS SHAPE
COLTENE/WHALEDENT INC
RLKS1SC012
In Commercial Distribution

  • D661RLKS1SC0121 ()
  • D661RLKS1SC0120 ()


  • Dental abrasive point, reusable
Diamond Shape
HENRY SCHEIN, INC.
5702838
In Commercial Distribution

  • 00304040162477 ()
  • 10304040162474 ()
5702838

  • Basic manual toothbrush
Cartilage Burr
WRIGHT MEDICAL TECHNOLOGY, INC.
58CF4008
In Commercial Distribution

  • 00889797103831 ()

  • Outer Diameter: 4 Millimeter
  • Shape: Flame
  • Length: 8 Millimeter
58CF4008

  • Orthopaedic bur, single-use
Sculpting Burr
WRIGHT MEDICAL TECHNOLOGY, INC.
58SC4016
In Commercial Distribution

  • 00889797103824 ()

  • Shape: Cyl
  • Outer Diameter: 4 Millimeter
  • Length: 16 Millimeter
58SC4016

  • Orthopaedic bur, single-use
Cartilage Burr
WRIGHT MEDICAL TECHNOLOGY, INC.
58CC4016
In Commercial Distribution

  • 00889797103817 ()

  • Shape: Cyl
  • Length: 16 Millimeter
  • Outer Diameter: 4 Millimeter
58CC4016

  • Orthopaedic bur, single-use
Sculpting Burr
WRIGHT MEDICAL TECHNOLOGY, INC.
58SC3012
In Commercial Distribution

  • 00889797103800 ()

  • Length: 12 Millimeter
  • Shape: Cyl
  • Outer Diameter: 3 Millimeter
58SC3012

  • Orthopaedic bur, single-use
Cartilage Burr
WRIGHT MEDICAL TECHNOLOGY, INC.
58CC3012
In Commercial Distribution

  • 00889797103794 ()

  • Outer Diameter: 3 Millimeter
  • Length: 12 Millimeter
  • Shape: Cyl
58CC3012

  • Orthopaedic bur, single-use
Sculpting Burr
WRIGHT MEDICAL TECHNOLOGY, INC.
58SC2008
In Commercial Distribution

  • 00889797103787 ()

  • Outer Diameter: 2 Millimeter
  • Length: 8 Millimeter
  • Shape: Cyl
58SC2008

  • Orthopaedic bur, single-use
Cartilage Burr
WRIGHT MEDICAL TECHNOLOGY, INC.
58CC2008
In Commercial Distribution

  • 00889797103770 ()

  • Outer Diameter: 2 Millimeter
  • Length: 8 Millimeter
  • Shape: Cyl
58CC2008

  • Orthopaedic bur, single-use
Cortical Burr
WRIGHT MEDICAL TECHNOLOGY, INC.
58RSPH40
In Commercial Distribution

  • 00889797103848 ()

  • Shape: Sphere
  • Outer Diameter: 4 Millimeter
58RSPH40

  • Orthopaedic bur, single-use
Cold-curing, methyl methacrylate resin intended specifically for injection moulding techniques (e.g. Unipress)
Schütz Dental GmbH
650062
In Commercial Distribution

  • ESDG6500621 ()


  • Dental appliance fabrication material, resin
Cold-curing, methyl methacrylate resin intended specifically for injection moulding techniques (e.g. Unipress)
Schütz Dental GmbH
650061
In Commercial Distribution

  • ESDG6500611 ()


  • Dental appliance fabrication material, resin
Cold-curing, methyl methacrylate resin intended specifically for injection moulding techniques (e.g. Unipress)
Schütz Dental GmbH
650050
In Commercial Distribution

  • ESDG6500501 ()


  • Dental appliance fabrication material, resin
Cold-curing, methyl methacrylate resin intended specifically for injection moulding techniques (e.g. Unipress)
Schütz Dental GmbH
650025
In Commercial Distribution

  • ESDG6500251 ()


  • Dental appliance fabrication material, resin
Cold-curing, methyl methacrylate resin intended specifically for injection moulding techniques (e.g. Unipress)
Schütz Dental GmbH
650024
In Commercial Distribution

  • ESDG6500241 ()


  • Dental appliance fabrication material, resin
Cold-curing, methyl methacrylate resin intended specifically for injection moulding techniques (e.g. Unipress)
Schütz Dental GmbH
650023
In Commercial Distribution

  • ESDG6500231 ()


  • Dental appliance fabrication material, resin
Cold-curing, methyl methacrylate resin intended specifically for injection moulding techniques (e.g. Unipress)
Schütz Dental GmbH
650022
In Commercial Distribution

  • ESDG6500221 ()


  • Dental appliance fabrication material, resin
Cold-curing, methyl methacrylate resin intended specifically for injection moulding techniques (e.g. Unipress)
Schütz Dental GmbH
650021
In Commercial Distribution

  • ESDG6500211 ()


  • Dental appliance fabrication material, resin
Cold-curing, methyl methacrylate resin intended specifically for injection moulding techniques (e.g. Unipress)
Schütz Dental GmbH
650020
In Commercial Distribution

  • ESDG6500201 ()


  • Dental appliance fabrication material, resin
Cold-curing, methyl methacrylate resin intended specifically for injection moulding techniques (e.g. Unipress)
Schütz Dental GmbH
650015
In Commercial Distribution

  • ESDG6500151 ()


  • Dental appliance fabrication material, resin
Cold-curing, methyl methacrylate resin intended specifically for injection moulding techniques (e.g. Unipress)
Schütz Dental GmbH
650014
In Commercial Distribution

  • ESDG6500141 ()


  • Dental appliance fabrication material, resin
Cold-curing, methyl methacrylate resin intended specifically for injection moulding techniques (e.g. Unipress)
Schütz Dental GmbH
650013
In Commercial Distribution

  • ESDG6500131 ()


  • Dental appliance fabrication material, resin
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