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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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OsteoMed - 00845694047562

Medium 2 x 4 Hole Quad Plate, Sterile
OSTEOMED LLC
212-0069-SP
In Commercial Distribution

  • 00845694047562 ()

  • Length: 18 Millimeter
212-0069-SP

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

OsteoMed - 00845694047555

12 Hole Curved Plate, Sterile
OSTEOMED LLC
212-0036-SP
In Commercial Distribution

  • 00845694047555 ()

  • Length: 47 Millimeter
212-0036-SP

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

OsteoMed - 00845694047548

18mm Hole Straight Plate, Sterile
OSTEOMED LLC
212-0034-SP
In Commercial Distribution

  • 00845694047548 ()

  • Length: 79 Millimeter
212-0034-SP

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

CirFIX® Cranial bone fixation system: Burr Hole Cover - 04717002404335

CUSMED CirFIX® Burr Hole Cover, Radiolucent Revisable Type for Shunt & ICP+Screwdriver, PEEK, 14mm/11mm, Sterile
OSSAWARE BIOTECH CO., LTD.
9906.0014.11S
In Commercial Distribution

  • 04717002404335 ()
  • 14717002404332 ()
  • 24717002404339 ()
9906.0014.11S

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

CirFIX® Cranial bone fixation system: Burr Hole Cover - 04717002404328

CUSMED CirFIX® Burr Hole Cover, Radiolucent Revisable Type+Screwdriver, PEEK, 14mm/11mm, Sterile
OSSAWARE BIOTECH CO., LTD.
9905.0014.11S
In Commercial Distribution

  • 14717002404325 ()
  • 04717002404328 ()
  • 24717002404322 ()
9905.0014.11S

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

N/A - 00613994792846

DRVR KIT 9734649 LGY G4 PEEK RDCTN DRVR
MEDTRONIC NAVIGATION, INC.
9734649
In Commercial Distribution

  • 00613994792846 ()


  • Surgical screwdriver, reusable

BioHorizons - 00847236007904

Snap Ring for Implant-level Drivers
BIOHORIZONS IMPLANT SYSTEMS, INC
PXIDSR
In Commercial Distribution

  • 00847236007904 ()


  • Surgical screwdriver, reusable

MicroAire® - 00847399005243

SST TWIST DRILL, AO TYPE, 3.2mm DIA. X 120mm
Microaire Surgical Instruments LLC
8053-031
In Commercial Distribution

  • 00847399005243 ()

  • Outer Diameter: 3.2 Millimeter
  • Length: 120 Millimeter


  • Cannulated surgical drill bit, single-use

MicroAire® - 00847399005236

SST TWIST DRILL, AO TYPE, 3.2mm DIA. X 170mm
Microaire Surgical Instruments LLC
8053-029
In Commercial Distribution

  • 00847399005236 ()

  • Outer Diameter: 3.2 Millimeter
  • Length: 170 Millimeter


  • Cannulated surgical drill bit, single-use

MicroAire® - 00847399005229

SST TWIST DRILL, AO TYPE, 2.7mm DIA. X 100mm
Microaire Surgical Instruments LLC
8053-028
In Commercial Distribution

  • 00847399005229 ()

  • Outer Diameter: 2.7 Millimeter
  • Length: 100 Millimeter


  • Cannulated surgical drill bit, single-use
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