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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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Materialise Personalized Solutions - 05420060343346

Pediatric Radius/Ulna Model
Materialise NV
UEA-MA10-00-01
In Commercial Distribution

UEA-MA10-00-01

  • Custom-made organ/bone anatomy model/surgical guide kit

Materialise Personalized Solutions - 05420060343285

Humerus Osteotomy Guide and Model
Materialise NV
O-01-0-105000-0011-010
In Commercial Distribution

O-01-0-105000-0011-010

  • Custom-made organ/bone anatomy model/surgical guide kit

Materialise Personalized Solutions - 05420060343278

Pediatric Radius/Ulna Osteotomy Guide and Model
Materialise NV
UEA-MA01-00-01
In Commercial Distribution

UEA-MA01-00-01

  • Custom-made organ/bone anatomy model/surgical guide kit

Materialise Personalized Solutions - 05420060343261

Radius/Ulna Osteotomy Guide and Model
Materialise NV
O-01-0-101000-0011-010
In Commercial Distribution

O-01-0-101000-0011-010

  • Custom-made organ/bone anatomy model/surgical guide kit

Materialise Personalized Solutions - 05420060343254

Bone Model Lower Extremity
Materialise NV
O-01-0-300000-0121-020
In Commercial Distribution

  • 05420060343254 ()
O-01-0-300000-0121-020

  • Custom-made organ/bone anatomy model/surgical guide kit

Materialise Personalized Solutions - 05420060343247

Bone Model Upper Extremity
Materialise NV
O-01-0-100000-0121-020
In Commercial Distribution

  • 05420060343247 ()
O-01-0-100000-0121-020

  • Custom-made organ/bone anatomy model/surgical guide kit

Materialise Personalized Solutions - 05420060343230

Acromion Osteotomy Model
Materialise NV
O-01-0-820000-0111-010
In Commercial Distribution

  • 05420060343230 ()
O-01-0-820000-0111-010

  • Custom-made organ/bone anatomy model/surgical guide kit

Materialise Personalized Solutions - 05420060343223

Acromion Osteotomy Guide
Materialise NV
O-01-0-820000-0211-010
In Commercial Distribution

  • 05420060343223 ()
O-01-0-820000-0211-010

  • Custom-made organ/bone anatomy model/surgical guide kit

Materialise Personalized Solutions - 05420060343209

Guide Lower Extremity
Materialise NV
O-01-0-300000-0221-010
In Commercial Distribution

  • 05420060343209 ()
O-01-0-300000-0221-010

  • Custom-made organ/bone anatomy model/surgical guide kit

Materialise Personalized Solutions - 05420060343186

Guide Upper Extremity
Materialise NV
O-01-0-100000-0221-010
In Commercial Distribution

  • 05420060343186 ()
O-01-0-100000-0221-010

  • Custom-made organ/bone anatomy model/surgical guide kit
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