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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
ELLIQUENCE, LLC
11-2514
In Commercial Distribution

  • 00846338002176 ()


  • Spinal endoscopic-access system
No Description
ELLIQUENCE, LLC
11-2513
In Commercial Distribution

  • 00846338002169 ()


  • Spinal endoscopic-access system
DRIVER T27 X0810812 NON BRK OFF QC X 290
MEDTRONIC SOFAMOR DANEK, INC.
X0810812
In Commercial Distribution

  • 00613994866035 ()


  • Surgical drill guide, reusable
DRIVER T27 X0810811 NON BRK OFF QC X 155
MEDTRONIC SOFAMOR DANEK, INC.
X0810811
In Commercial Distribution

  • 00613994866028 ()


  • Surgical drill guide, reusable
DRIVER T27 X0810810 REDUCTION QC X 290
MEDTRONIC SOFAMOR DANEK, INC.
X0810810
In Commercial Distribution

  • 00613994866011 ()


  • Surgical drill guide, reusable
DRIVER T27 X0810809 REDUCTION QC X 155
MEDTRONIC SOFAMOR DANEK, INC.
X0810809
In Commercial Distribution

  • 00613994866004 ()


  • Surgical drill guide, reusable
DRIVER EX0710385 LOCKABLE MAS
MEDTRONIC SOFAMOR DANEK, INC.
EX0710385
In Commercial Distribution

  • 00613994862464 ()


  • Orthopaedic implant driver
6.35 DRIVER EX0810680 SHORT
MEDTRONIC SOFAMOR DANEK, INC.
EX0810680
Not in Commercial Distribution

  • 00613994862402 ()


  • Surgical drill guide, reusable
SCREW DRIVER EX07101280 5.5 SHORT
MEDTRONIC SOFAMOR DANEK, INC.
EX07101280
In Commercial Distribution

  • 00613994853554 ()


  • Orthopaedic implant driver
DRIVER EX0810184 6 MM DIAM, 334MM LENGTH
MEDTRONIC SOFAMOR DANEK, INC.
EX0810184
In Commercial Distribution

  • 00613994853547 ()


  • Orthopaedic implant driver
DRIVER KIT 9734644 LGY G4 STANDARD
MEDTRONIC NAVIGATION, INC.
9734644
In Commercial Distribution

  • 00613994853516 ()


  • Surgical screwdriver, reusable
DRIVER EX0710362 3.5 CAPTIVE TWIST HEX
MEDTRONIC SOFAMOR DANEK, INC.
EX0710362
In Commercial Distribution

  • 00613994852649 ()


  • Orthopaedic implant driver
DRIVER EX0710429 PEEK ROD MAS DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
EX0710429
In Commercial Distribution

  • 00613994850102 ()


  • Orthopaedic implant driver
DRIVER EX0710430 PROVISIONAL DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
EX0710430
In Commercial Distribution

  • 00613994850096 ()


  • Orthopaedic implant driver
NUT DRIVER EX0610088 TORQUE LIMITING
MEDTRONIC SOFAMOR DANEK, INC.
EX0610088
In Commercial Distribution

  • 00613994846129 ()


  • Orthopaedic implant driver
Implant Adaptor
COHO BIOMEDICAL TECHNOLOGY CO., LTD.
Me-A4815
In Commercial Distribution

  • 04710986432646 ()


  • Surgical torque wrench adaptor
Poly Axial Screw Driver
BAUI BIOTECH CO. LTD.
409-0836B
In Commercial Distribution

  • 04710577043510 ()


  • 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
Poly Axial Screw Adjustable Driver
BAUI BIOTECH CO. LTD.
409-0813B
In Commercial Distribution

  • 04710577040939 ()


  • 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
1.6 System Right Pterional Mesh Sterile Qty 2
OSTEOMED LLC
218-2016-SP-02
In Commercial Distribution

  • 00845694066082 ()

  • Length: 92 Millimeter
218-2016-SP-02

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
1.6 System Left Pterional Mesh Sterile Qty 2
OSTEOMED LLC
218-2015-SP-02
In Commercial Distribution

  • 00845694066068 ()

  • Length: 92 Millimeter
218-2015-SP-02

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile 0 65 x 90mm Mesh Sterile Qty 1
OSTEOMED LLC
218-0290-SP-01
In Commercial Distribution

  • 00845694065986 ()

  • Length: 90 Millimeter
218-0290-SP-01

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile 0 80 x 50mm Mesh Sterile Qty 1
OSTEOMED LLC
218-0285-SP-01
In Commercial Distribution

  • 00845694065962 ()

  • Length: 79 Millimeter
218-0285-SP-01

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile 0 2 Long Straight Plate Sterile Qty 5
OSTEOMED LLC
218-0217-SP-05
In Commercial Distribution

  • 00845694065948 ()

  • Length: 19 Millimeter
218-0217-SP-05

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile 0 45 Gap Plate Sterile Qty 2
OSTEOMED LLC
218-0216-SP-02
In Commercial Distribution

  • 00845694065924 ()

  • Length: 50 Millimeter
218-0216-SP-02

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile 0 35 Gap Plate Sterile Qty 2
OSTEOMED LLC
218-0215-SP-02
In Commercial Distribution

  • 00845694065900 ()

  • Length: 39 Millimeter
218-0215-SP-02

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile 0 25 Gap Plate Sterile Qty 2
OSTEOMED LLC
218-0214-SP-02
In Commercial Distribution

  • 00845694065887 ()

  • Length: 29 Millimeter
218-0214-SP-02

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile 0 Bur Hole Groove Shunt Plate Sterile Qty 5
OSTEOMED LLC
218-0213-SP-05
In Commercial Distribution

  • 00845694065863 ()

  • Outer Diameter: 27 Millimeter
218-0213-SP-05

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile 0 X- Large Bur Hole Plate Sterile Qty 2
OSTEOMED LLC
218-0212-SP-02
In Commercial Distribution

  • 00845694065849 ()

  • Outer Diameter: 31 Millimeter
218-0212-SP-02

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