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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A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
ENZTEC LIMITED
4240-3060
In Commercial Distribution

  • 09421028112529 ()
4240-3060

  • Orthopaedic implant impactor, reusable
No Description
Biomet Uk Ltd
31-555512
In Commercial Distribution

  • 05019279923380 ()
31-555512

  • Hand-held surgical retractor, reusable
RBK Patello Femoral Size 4 Right
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
GO-6000-4PFR-01
Not in Commercial Distribution

  • 09340499022710 ()

  • Size 4
GO-6000-4PFR-01

  • Uncoated knee femur prosthesis, metallic
RBK Patello Femoral Size 4 Left
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
GO-6000-4PFL-01
Not in Commercial Distribution

  • 09340499022703 ()

  • Size 4
GO-6000-4PFL-01

  • Uncoated knee femur prosthesis, metallic
RBK Patello Femoral Size 3 Right
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
GO-6000-3PFR-01
Not in Commercial Distribution

  • 09340499017808 ()

  • Size 3
GO-6000-3PFR-01

  • Uncoated knee femur prosthesis, metallic
RBK Patello Femoral Size 3 Left
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
GO-6000-3PFL-01
Not in Commercial Distribution

  • 09340499017792 ()

  • Size 3
GO-6000-3PFL-01

  • Uncoated knee femur prosthesis, metallic
RBK Patello Femoral Size 2 Right
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
GO-6000-2PFR-01
Not in Commercial Distribution

  • 09340499017785 ()

  • Size 2
GO-6000-2PFR-01

  • Uncoated knee femur prosthesis, metallic
RBK Patello Femoral Size 2 Left
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
GO-6000-2PFL-01
Not in Commercial Distribution

  • 09340499017778 ()

  • Size 2
GO-6000-2PFL-01

  • Uncoated knee femur prosthesis, metallic
RBK Patello Femoral Size 1 Right
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
GO-6000-1PFR-01
Not in Commercial Distribution

  • 09340499017761 ()

  • Size 0
GO-6000-1PFR-01

  • Uncoated knee femur prosthesis, metallic
RBK Patello Femoral Size 1 Left
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
GO-6000-1PFL-01
Not in Commercial Distribution

  • 09340499017754 ()

  • Size 1
GO-6000-1PFL-01

  • Uncoated knee femur prosthesis, metallic
RBK Patello Femoral Size 0 Right
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
GO-6000-0PFR-01
Not in Commercial Distribution

  • 09340499017747 ()

  • Size 0
GO-6000-0PFR-01

  • Uncoated knee femur prosthesis, metallic
RBK Patello Femoral Size 0 Left
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
GO-6000-0PFL-01
Not in Commercial Distribution

  • 09340499017730 ()

  • Size 0
GO-6000-0PFL-01

  • Uncoated knee femur prosthesis, metallic
RBK Patella 40mm
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
GO-1003-40-00
Not in Commercial Distribution

  • 09340499004662 ()

  • 40 mm
GO-1003-40-00

  • Polyethylene patella prosthesis
RBK Patella 36mm
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
GO-1003-36-00
Not in Commercial Distribution

  • 09340499004655 ()

  • 36 mm
GO-1003-36-00

  • Polyethylene patella prosthesis
RBK Patella 32mm
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
GO-1003-32-00
Not in Commercial Distribution

  • 09340499004648 ()

  • 32 mm
GO-1003-32-00

  • Polyethylene patella prosthesis
RBK Patella 28mm
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
GO-1003-28-00
Not in Commercial Distribution

  • 09340499004631 ()

  • 28 mm
GO-1003-28-00

  • Polyethylene patella prosthesis
RBK Patella 24mm
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
GO-1003-24-00
Not in Commercial Distribution

  • 09340499004624 ()

  • 24mm
GO-1003-24-00

  • Polyethylene patella prosthesis
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-152-003
In Commercial Distribution

  • 09348215017903 ()


  • Metallic femoral head prosthesis
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-152-002
In Commercial Distribution

  • 09348215017897 ()


  • Metallic femoral head prosthesis
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-152-001
In Commercial Distribution

  • 09348215017880 ()


  • Metallic femoral head prosthesis
Ø4.8mm Locking Bolt, Self-Tapping, For Expert Femoral Nail, Length 85mm, Titanium
Auxein Medical Private Limited
TI-1458-4.8-085
In Commercial Distribution

  • 08903993408773 ()


  • Orthopaedic bone screw (non-sliding)
Ø4.8mm Locking Bolt, Self Tapping, Length 80mm, Titanium (For Expert Femoral Nail)
Auxein Medical Private Limited
TI-1458-4.8-080
In Commercial Distribution

  • 08903993408766 ()


  • Orthopaedic bone screw (non-sliding)
Ø4.8mm Locking Bolt, Self Tapping, Length 68mm, Titanium (For Expert Femoral Nail)
Auxein Medical Private Limited
TI-1458-4.8-068
In Commercial Distribution

  • 08903993408742 ()


  • Femur intramedullary nail
Ø4.8mm Locking Bolt, Self Tapping, Length 66mm, Titanium (For Expert Femoral Nail)
Auxein Medical Private Limited
TI-1458-4.8-066
In Commercial Distribution

  • 08903993408735 ()


  • Orthopaedic bone screw (non-sliding)
Ø4.8mm Locking Bolt, Self Tapping, Length 60mm, Titanium (For Expert Femoral Nail)
Auxein Medical Private Limited
TI-1458-4.8-060
In Commercial Distribution

  • 08903993389652 ()


  • Orthopaedic bone screw (non-sliding)
Ø4.8mm Locking Bolt, Self Tapping, Length 58mm, Titanium (For Expert Femoral Nail)
Auxein Medical Private Limited
TI-1458-4.8-058
In Commercial Distribution

  • 08903993377055 ()


  • Orthopaedic bone screw (non-sliding)
Ø4.8mm Locking Bolt, Self Tapping, Length 50mm, Titanium (For Expert Femoral Nail)
Auxein Medical Private Limited
TI-1458-4.8-050
In Commercial Distribution

  • 08903993377017 ()


  • Orthopaedic bone screw (non-sliding)
Ø4.8mm Locking Bolt, Self Tapping, Length 46mm, Titanium (For Expert Femoral Nail)
Auxein Medical Private Limited
TI-1458-4.8-046
In Commercial Distribution

  • 08903993376997 ()


  • Orthopaedic bone screw (non-sliding)
Ø4.8mm Locking Bolt, Self Tapping, Length 44mm, Titanium (For Expert Femoral Nail)
Auxein Medical Private Limited
TI-1458-4.8-044
In Commercial Distribution

  • 08903993376980 ()


  • Orthopaedic bone screw (non-sliding)
Ø4.8mm Locking Bolt, Self Tapping, Length 42mm, Titanium (For Expert Femoral Nail)
Auxein Medical Private Limited
TI-1458-4.8-042
In Commercial Distribution

  • 08903993376973 ()


  • Orthopaedic bone screw (non-sliding)
Ø4.8mm Locking Bolt, Self Tapping, Length 38mm, Titanium (For Expert Femoral Nail)
Auxein Medical Private Limited
TI-1458-4.8-038
In Commercial Distribution

  • 08903993376959 ()


  • Orthopaedic bone screw (non-sliding)
Ø4.8mm Locking Bolt, Self Tapping, Length 34mm, Titanium (For Expert Femoral Nail)
Auxein Medical Private Limited
TI-1458-4.8-034
In Commercial Distribution

  • 08903993376935 ()


  • Orthopaedic bone screw (non-sliding)
Ø4.8mm Locking Bolt, Self Tapping, Length 30mm, Titanium (For Expert Femoral Nail)
Auxein Medical Private Limited
TI-1458-4.8-030
In Commercial Distribution

  • 08903993376911 ()


  • Orthopaedic bone screw (non-sliding)
Ø6.4mm Cannulated Anti-Rotation Screw, Length 125mm (For Expert Femoral Nail)
Auxein Medical Private Limited
TI-1459-125
In Commercial Distribution

  • 08903993376874 ()


  • Orthopaedic bone screw (non-sliding)
End Cap For Expert Femoral Nail, Length 20mm, Titanium
Auxein Medical Private Limited
TI-1459-20
In Commercial Distribution

  • 08903993376850 ()


  • Bone nail end-cap
Expert Femoral Nail, Left, Ø12mm x Length 340mm, Titanium
Auxein Medical Private Limited
TI-1459-12-340L
In Commercial Distribution

  • 08903993376447 ()


  • Femur intramedullary nail
Femoral Trial - Size 10, Right
B-ONE ORTHO, CORP.
8829P00066
In Commercial Distribution

  • 00843575112828 ()
8829P00066

  • Knee femur prosthesis trial, reusable
Femoral Trial - Size 10, Left
B-ONE ORTHO, CORP.
8829P00065
In Commercial Distribution

  • 00843575112811 ()
8829P00065

  • Knee femur prosthesis trial, reusable
Femoral Trial - Size 9, Right
B-ONE ORTHO, CORP.
8829P00064
In Commercial Distribution

  • 00843575112804 ()
8829P00064

  • Knee femur prosthesis trial, reusable
Femoral Trial - Size 9, Left
B-ONE ORTHO, CORP.
8829P00063
In Commercial Distribution

  • 00843575112798 ()
8829P00063

  • Knee femur prosthesis trial, reusable
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