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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15mm Left L Rigid Plate, 2pk, Sterile
OSTEOMED LLC
210-0208-SP-02
In Commercial Distribution

  • 00845694033152 ()

  • Length: 16 Millimeter
210-0208-SP-02

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
23MM RIGHT L RIGID PLATE & 23MM LEFT L RIGID PLATE, STERILE
OSTEOMED LLC
210-0151-SP
In Commercial Distribution

  • 00845694033145 ()

  • Length: 23 Millimeter
210-0151-SP

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
18mm Right L Rigid Plate & 18mm Left L Rigid Plate, Sterile
OSTEOMED LLC
210-0150-SP
In Commercial Distribution

  • 00845694033138 ()

  • Length: 18 Millimeter
210-0150-SP

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
15mm Right L Plate & 15mm Left L Plate, Sterile
OSTEOMED LLC
210-0149-SP
In Commercial Distribution

  • 00845694033121 ()

  • Length: 15 Millimeter
210-0149-SP

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
5mm Chin Plate
OSTEOMED LLC
210-0062
In Commercial Distribution

  • 00845694033114 ()

  • Advancement = 5mm
210-0062

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Mini 18mm Left L Plate, Sterile
OSTEOMED LLC
210-0012-SP
In Commercial Distribution

  • 00845694033107 ()

  • Length: 18 Millimeter
210-0012-SP

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
1.6mm Short CA Driver Stem, Dental Latch
OSTEOMED LLC
220-0390
In Commercial Distribution

  • 00845694031561 ()
220-0390

  • General internal orthopaedic fixation system implantation kit
1.6mm Modified LeFort Plate, Right, 8mm
OSTEOMED LLC
213-0213
In Commercial Distribution

  • 00845694031530 ()

  • Span Length = 8mm
213-0213

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
1.6mm Modified LeFort Plate, Left, 8mm
OSTEOMED LLC
213-0212
In Commercial Distribution

  • 00845694031523 ()

  • Span Length = 8mm
213-0212

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
1.6mm Modified LeFort Plate, Right, 7mm
OSTEOMED LLC
213-0211
In Commercial Distribution

  • 00845694031516 ()

  • Span Length = 7mm
213-0211

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
1.6mm Modified LeFort Plate, Left, 7mm
OSTEOMED LLC
213-0210
In Commercial Distribution

  • 00845694031509 ()

  • Span Length = 7mm
213-0210

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
1.6mm Modified LeFort Plate, Right, 6mm
OSTEOMED LLC
213-0209
In Commercial Distribution

  • 00845694031493 ()

  • Span Length = 6mm
213-0209

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
11mm Chin Plate
OSTEOMED LLC
210-0065
In Commercial Distribution

  • 00845694031325 ()

  • Advancement = 11mm
210-0065

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
ISO Chin Plate, 8mm
OSTEOMED LLC
210-0401
In Commercial Distribution

  • 00845694028448 ()

  • Advancement = 8mm
210-0401

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MFx Angulated Locking Fracture Plate, 3 x 3 Hole
OSTEOMED LLC
214-2409
In Commercial Distribution

  • 00845694026635 ()

  • Thickness = 1.5mm
214-2409

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MFx Angulated Locking Fracture Plate, 8 Hole, 59mm
OSTEOMED LLC
214-2407
In Commercial Distribution

  • 00845694026611 ()

  • Length: 59 Millimeter
214-2407

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MFx Angulated Locking Fracture Plate, 6 Hole, 52mm
OSTEOMED LLC
214-2406
In Commercial Distribution

  • 00845694026604 ()

  • Length: 52 Millimeter
214-2406

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MFx Angulated Locking Curved Plate, 5 Hole
OSTEOMED LLC
214-2010
In Commercial Distribution

  • 00845694026505 ()

  • Length: 27 Millimeter
214-2010

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MFx Angulated Locking Straight Plate, 6 Hole
OSTEOMED LLC
214-2009
In Commercial Distribution

  • 00845694026499 ()

  • Length: 34 Millimeter
214-2009

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MFx Angulated Locking Curved Plate, 9 Hole
OSTEOMED LLC
214-2007
In Commercial Distribution

  • 00845694026475 ()

  • Length: 47 Millimeter
214-2007

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MFx Angulated Locking Straight Plate, 18 Hole
OSTEOMED LLC
214-2005
In Commercial Distribution

  • 00845694026451 ()

  • Length: 80 Millimeter
214-2005

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MFx Angulated Locking Comminution Plate
OSTEOMED LLC
214-2004
In Commercial Distribution

  • 00845694026444 ()

  • Length: 117 Millimeter
214-2004

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MFx Angulated Locking BSSO Plate, 4 Hole, Short
OSTEOMED LLC
214-2003
In Commercial Distribution

  • 00845694026437 ()

  • Length: 25 Millimeter
214-2003

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MFx Angulated Locking BSSO Plate, 4 Hole, Long
OSTEOMED LLC
214-2002
In Commercial Distribution

  • 00845694026420 ()

  • Length: 33 Millimeter
214-2002

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MFx Angulated Locking BSSO Plate, 4 Hole, Medium
OSTEOMED LLC
214-2001
In Commercial Distribution

  • 00845694026413 ()

  • Length: 29 Millimeter
214-2001

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
DRIVER 962016S CDH LEGACY MAS REDUCTION
MEDTRONIC NAVIGATION, INC.
962016S
Not in Commercial Distribution

  • 00613994602220 ()


  • Surgical screwdriver, reusable
DRIVER 2-2003 HEX TORQUE LIM X STOP US
MEDTRONIC SOFAMOR DANEK, INC.
2-2003
In Commercial Distribution

  • 00613994598578 ()


  • Surgical screwdriver, reusable
DRIVER 8350394 PRIMARY SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
8350394
In Commercial Distribution

  • 00613994597809 ()


  • Orthopaedic stereotactic surgery system
DRIVER 8350393 PRIMARY
MEDTRONIC SOFAMOR DANEK, INC.
8350393
In Commercial Distribution

  • 00613994597793 ()

  • 3.2mm Hex


  • Orthopaedic implant driver
DRIVER X0409176 BIT ROOK
MEDTRONIC SOFAMOR DANEK, INC.
X0409176
In Commercial Distribution

  • 00613994596383 ()


  • Surgical drill guide, reusable
DRIVER 2342280S 4.75 FAS S
MEDTRONIC SOFAMOR DANEK, INC.
2342280S
In Commercial Distribution

  • 00613994649737 ()


  • Bone tap, reusable
DRIVER 2342393L POST L
MEDTRONIC SOFAMOR DANEK, INC.
2342393L
In Commercial Distribution

  • 00613994649690 ()


  • Surgical screwdriver, reusable
DRIVER 2342393M POST M
MEDTRONIC SOFAMOR DANEK, INC.
2342393M
In Commercial Distribution

  • 00613994649683 ()


  • Surgical screwdriver, reusable
DRIVER 2342393S POST S
MEDTRONIC SOFAMOR DANEK, INC.
2342393S
In Commercial Distribution

  • 00613994649676 ()


  • Surgical screwdriver, reusable
No Description
Biomet Uk Ltd
31-555522
In Commercial Distribution

  • 05019279923458 ()
31-555522

  • Surgical instrument handle, non-torque-limiting
No Description
Biomet Uk Ltd
31-476948
In Commercial Distribution

  • 05019279909070 ()
31-476948

  • Orthopaedic implant driver
No Description
Biomet Uk Ltd
32-420932
In Commercial Distribution

  • 05019279905638 ()
32-420932

  • Orthopaedic implant impactor, reusable
No Description
7D Surgical ULC
11-0097
In Commercial Distribution

  • 00628341520867 ()


  • Surgical screwdriver, reusable
No Description
7D Surgical ULC
11-0078
In Commercial Distribution

  • 00628341520676 ()


  • Surgical screwdriver, reusable
No Description
7D Surgical ULC
11-0058
In Commercial Distribution

  • 00628341520515 ()


  • Surgical screwdriver, reusable
No Description
7D Surgical ULC
11-0029
In Commercial Distribution

  • 00628341520164 ()


  • Surgical screwdriver, reusable
No Description
7D Surgical ULC
11-0023
In Commercial Distribution

  • 00628341520126 ()


  • Surgical screwdriver, reusable
No Description
Biomet Uk Ltd
31-301921
In Commercial Distribution

  • 05019279431564 ()

  • 3.5 mm
31-301921

  • Surgical screwdriver, reusable
No Description
Biomet Uk Ltd
32-420660
In Commercial Distribution

  • 05019279487516 ()
32-420660

  • Orthopaedic implant driver
No Description
Biomet Uk Ltd
31-473600
In Commercial Distribution

  • 05019279457359 ()
31-473600

  • Surgical mallet
No Description
Biomet Orthopedics, LLC
31-555527
In Commercial Distribution

  • 05019279298211 ()
31-555527

  • Surgical screwdriver, reusable
Endotine Midface B Installation Tool
Microaire Surgical Instruments LLC
CFD-020-4250
Not in Commercial Distribution

  • 00847399006738 ()


  • Surgical screwdriver, reusable
SST TWIST DRILL, STANDARD, 2.8mm Dia. x 127mm
Microaire Surgical Instruments LLC
8054-013
In Commercial Distribution

  • 00847399005557 ()

  • Outer Diameter: 2.8 Millimeter
  • Length: 127 Millimeter


  • Cannulated surgical drill bit, single-use
SST TWIST DRILL, STANDARD, 2.4mm Dia. x 127mm
Microaire Surgical Instruments LLC
8054-012
In Commercial Distribution

  • 00847399005533 ()

  • Outer Diameter: 2.4 Millimeter
  • Length: 127 Millimeter


  • Cannulated surgical drill bit, single-use
SST TWIST DRILL, AO TYPE, 6mm DIA. X 170mm
Microaire Surgical Instruments LLC
8053-060
Not in Commercial Distribution

  • 00847399005342 ()

  • Outer Diameter: 6 Millimeter
  • Length: 170 Millimeter


  • Cannulated surgical drill bit, single-use
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