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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 - 05420060343315

Tibia/Fibula Osteotomy Guide and Model
Materialise NV
O-01-0-303000-0011-010
In Commercial Distribution

O-01-0-303000-0011-010

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

Materialise Personalized Solutions - 05420060343308

Clavicle Osteotomy Guide and Model
Materialise NV
O-01-0-828000-0011-000
In Commercial Distribution

O-01-0-828000-0011-000

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

Materialise Personalized Solutions - 05420060343292

Hand Osteotomy Guide and Model
Materialise NV
O-01-0-200000-0011-010
In Commercial Distribution

O-01-0-200000-0011-010

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

Synchronis - 00850015884221

Chest Tube Valve Nonsterile
Synchronis Medical, LLC
2161-50000
In Commercial Distribution

  • 00850015884238 ()
  • 00850015884221 ()
2161-50000

  • Pleural drainage valve

canturio™ te Modular Bracket, Impaction Sleeve - 00850015699108

CTE Instruments are stored in an Instrument Tray which has no contact with the patient. Within the tray, the Instruments are held in place by reusable Modular Brackets that contact the Instruments during sterilization and storage (while inside the Tray), but have no patient contact themselves.
Canary Medical USA LLC
110044505
In Commercial Distribution

  • 00850015699108 ()


  • Device sterilization/disinfection container, reusable

canturio™te Canary Tibial Ext 14x58mm X-Ray Template - 00850015699092

The CTE 14mm x 58mm X-Ray Template is a surgical instrument used to assist the surgeon during preoperative planning.
Canary Medical USA LLC
43-5570-004-14
In Commercial Distribution

  • 00850015699092 ()


  • Surgical implant template, reusable

canturio™te Modular Bracket Tibial Cutting Guide, Left; 5 Deg. - 00850015699078

Tibial Cutting guide is placed within a tray, held in place by reusable Modular Brackets that contact the Instruments during sterilization and storage (while inside the Tray), but have no patient contact themselves.
Canary Medical USA LLC
43-5907-080-27
In Commercial Distribution

  • 00850015699078 ()


  • Device sterilization/disinfection container, reusable

TaperFit Cemented Hip System - 05055196941670

TOMMY BAR
CORIN LTD
340.328
In Commercial Distribution

  • 05055196941670 ()
340.328

  • Orthopaedic implant-instrument extension adaptor, reusable

C-Fit & DC-Fit Acetabular Cup System - 05055196941243

DCFIT CUP INSERT OFF
CORIN LTD
152.632
In Commercial Distribution

  • 05055196941243 ()
152.632

  • Non-constrained polyethylene acetabular liner

C-Fit & DC-Fit Acetabular Cup System - 05055196941236

DCFIT CUP INSERT OFF
CORIN LTD
152.532
In Commercial Distribution

  • 05055196941236 ()
152.532

  • Non-constrained polyethylene acetabular liner
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