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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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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
COPAL® knee moulds are sterile single-use moulds used for the preparation of spacers that are intended as temporary knee replacements as part of two-stage septic joint prosthesis revision. COPAL® knee moulds comprise a tibial component and a femoral component, which together form a bearing and move against one another. They can be used in both the right and the left knee joint. The spacer function provides that after removal of the prosthesis the existing joint space is retained and contraction of the musculature and the surrounding tissues is prevented. COPAL® knee moulds are intended for single use and must not be re-used or resterilised.
Heraeus Medical GmbH
L
In Commercial Distribution

  • 04260102139299 ()
  • 04260102139305 ()
  • 04260102139312 ()
5159870

  • Orthopaedic cement spacer mould
COPAL® knee moulds are sterile single-use moulds used for the preparation of spacers that are intended as temporary knee replacements as part of two-stage septic joint prosthesis revision. COPAL® knee moulds comprise a tibial component and a femoral component, which together form a bearing and move against one another. They can be used in both the right and the left knee joint. The spacer function provides that after removal of the prosthesis the existing joint space is retained and contraction of the musculature and the surrounding tissues is prevented COPAL® knee moulds are intended for single use and must not be re-used or resterilised.
Heraeus Medical GmbH
S
In Commercial Distribution

  • 04260102139244 ()
  • 04260102139237 ()
  • 04260102139251 ()
5159868

  • Orthopaedic cement spacer mould
COPAL® knee moulds are sterile single-use moulds used for the preparation of spacers that are intended as temporary knee replacements as part of two-stage septic joint prosthesis revision. COPAL® knee moulds comprise a tibial component and a femoral component, which together form a bearing and move against one another. They can be used in both the right and the left knee joint. The spacer function provides that after removal of the prosthesis the existing joint space is retained and contraction of the musculature and the surrounding tissues is prevented. COPAL® knee moulds are intended for single use and must not be re-used or resterilised.
Heraeus Medical GmbH
M
In Commercial Distribution

  • 04260102139275 ()
  • 04260102139268 ()
  • 04260102139282 ()
5159869

  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
431391
In Commercial Distribution

  • 00880304683037 ()

  • 91MM
431391

  • Orthopaedic cement spacer mould
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