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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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Profile Zero Retrosigmoid Plate
OSTEOMED LLC
218-0226
In Commercial Distribution

  • 00845694090742 ()

  • Length: 56 Millimeter
218-0226

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile Zero Translabyrinthine Plate
OSTEOMED LLC
218-0225
In Commercial Distribution

  • 00845694090735 ()

  • Length: 73 Millimeter
218-0225

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile Zero MVD Plate
OSTEOMED LLC
218-0224
In Commercial Distribution

  • 00845694090728 ()

  • Length: 39 Millimeter
218-0224

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile Zero Temporal Plate
OSTEOMED LLC
218-0223
In Commercial Distribution

  • 00845694090711 ()

  • Length: 91 Millimeter
218-0223

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile 0 Shunt Plate, Wide Groove
OSTEOMED LLC
218-0228
In Commercial Distribution

  • 00845694089098 ()

  • Outer Diameter: 27 Millimeter
218-0228

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
1.6mm Driver Stem, Hex SPD, Short
OSTEOMED LLC
220-0217
In Commercial Distribution

  • 00845694089081 ()

  • Length: 1.71 Inch
220-0217

  • General internal orthopaedic fixation system implantation kit
Poly Axial Screw Driver
BAUI BIOTECH CO. LTD.
409-0836B
In Commercial Distribution

  • 04710577043510 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Hex Nut Screw Driver
BAUI BIOTECH CO. LTD.
409-0829F
In Commercial Distribution

  • 04710577043473 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
5mm Hex Set Screw Driver
BAUI BIOTECH CO. LTD.
409-0829B
In Commercial Distribution

  • 04710577041691 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
1.8mm Cannulated Drill, Sterile, Qty 5
OSTEOMED LLC
320-5218-SP-05
In Commercial Distribution

  • 00845694094894 ()

  • Length: 116 Millimeter
320-5218-SP-05

  • Cannulated surgical drill bit, single-use
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