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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5RT Symmetric TK Femoral Component
SIGNAL MEDICAL CORPORATION
5RT
In Commercial Distribution

  • B0462201021050 ()
22-01-02105

  • Coated knee femur prosthesis
4RT Symmetric TK Femoral Component
SIGNAL MEDICAL CORPORATION
4RT
In Commercial Distribution

  • B046220102104 ()
22-01-02104

  • Coated knee femur prosthesis
3RT Symmetric TK Femoral Component
SIGNAL MEDICAL CORPORATION
3RT
In Commercial Distribution

  • B0462201021030 ()
22-01-02103

  • Coated knee femur prosthesis
7LT Symmetric TK Femoral Component
SIGNAL MEDICAL CORPORATION
7LT
In Commercial Distribution

  • B0462201020070 ()
22-01-02007

  • Coated knee femur prosthesis
Symmetric TK Femoral Component 6LT
SIGNAL MEDICAL CORPORATION
6LT
In Commercial Distribution

  • B0462201020060 ()
22-01-02006

  • Coated knee femur prosthesis
5LT Symmetric TK Femoral Component
SIGNAL MEDICAL CORPORATION
5LT
In Commercial Distribution

  • B0462201020050 ()
22-01-02005

  • Coated knee femur prosthesis
4LT Symmetric TK Femoral Component
SIGNAL MEDICAL CORPORATION
4LT
In Commercial Distribution

  • B0462201020040 ()
22-01-02004

  • Coated knee femur prosthesis
3LT Symmetric TK Femoral Component
SIGNAL MEDICAL CORPORATION
3LT
In Commercial Distribution

  • B0462201020030 ()
22-01-02003

  • Coated knee femur prosthesis
Long Femoral Nail Assy Ø3.2mm
Orthopediatrics Canada ULC
FD-032(L)-SS
In Commercial Distribution

  • 07540194000262 ()

  • Length: 202 Millimeter
  • Outer Diameter: 3.2 Millimeter
FD-032(L)-SS

  • Arthrodesis intramedullary nail, non-distracting
Femoral Augment Screw, Distal, 5mm
TOTAL JOINT ORTHOPEDICS, INC.
6407.00.005
In Commercial Distribution

  • 00814703019982 ()

  • 5mm


  • Implantable orthopaedic/craniofacial device connection screw
Hinge Femoral Distal Augment Trial
Howmedica Osteonics Corp.
6543-6-176
In Commercial Distribution

  • 07613327565478 ()

  • Size: 5
  • Size: 6
  • Thickness: 5.0 Millimeter
6543-6-176

  • Knee femur prosthesis trial, reusable
Hinge Femoral Distal Augment Trial
Howmedica Osteonics Corp.
6543-6-177
In Commercial Distribution

  • 07613327565461 ()

  • Thickness: 10.0 Millimeter
  • Size: 5
  • Size: 6
6543-6-177

  • Knee femur prosthesis trial, reusable
Hinge Femoral Distal Augment Trial
Howmedica Osteonics Corp.
6543-6-173
In Commercial Distribution

  • 07613327565454 ()

  • Thickness: 5.0 Millimeter
  • Size: 3
  • Size: 4
6543-6-173

  • Knee femur prosthesis trial, reusable
Hinge Femoral Distal Augment Trial
Howmedica Osteonics Corp.
6543-6-170
In Commercial Distribution

  • 07613327565393 ()

  • Size: 2
  • Thickness: 5.0 Millimeter
  • Size: 1
6543-6-170

  • Knee femur prosthesis trial, reusable
Hinge Femoral Trials - Right Tray
Howmedica Osteonics Corp.
6543-6-516
In Commercial Distribution

  • 07613327562651 ()
6543-6-516

  • Instrument tray, reusable
TS Femoral Trials - Left Tray
Howmedica Osteonics Corp.
6543-6-509
In Commercial Distribution

  • 07613327554083 ()
6543-6-509

  • Instrument tray, reusable
HIP FEMORAL RESURFACING CUP - 38MM
Synovo Production
01-03-0038
In Commercial Distribution

  • 00814193025739 ()

  • Outer Diameter: 38 Millimeter


  • Resurfacing metallic hip prosthesis
HIP FEMORAL RESURFACING CUP 39.5MM
Synovo Production
01-03-0039
In Commercial Distribution

  • 00814193025722 ()

  • Outer Diameter: 39.5 Millimeter
01-03-0039

  • Resurfacing metallic hip prosthesis
HIP FEMORAL RESURFACING CUP 41MM
Synovo Production
01-03-0041
In Commercial Distribution

  • 00814193025715 ()

  • Outer Diameter: 41 Millimeter


  • Resurfacing metallic hip prosthesis
HIP FEMORAL RESURFACING CUP - 42.5MM
Synovo Production
01-03-0042
In Commercial Distribution

  • 00814193025708 ()

  • Outer Diameter: 42.5 Millimeter
01-03-0042

  • Resurfacing metallic hip prosthesis
HIP FEMORAL RESURFACING CUP - 44MM
Synovo Production
01-03-0044
In Commercial Distribution

  • 00814193025678 ()

  • Outer Diameter: 44 Millimeter
01-03-0044

  • Resurfacing metallic hip prosthesis
HIP FEMORAL RESURFACING CUP - 51MM
Synovo Production
01-03-0051
In Commercial Distribution

  • 00814193025661 ()

  • Outer Diameter: 51 Millimeter
01-03-0051

  • Resurfacing metallic hip prosthesis
HIP FEMORAL RESURFACING CUP - 49MM
Synovo Production
01-03-0049
In Commercial Distribution

  • 00814193025654 ()

  • Outer Diameter: 49 Millimeter
01-03-0049

  • Resurfacing metallic hip prosthesis
Hinge Distal Femoral Resection Guide
Howmedica Osteonics Corp.
6543-6-040
In Commercial Distribution

  • 07613327519891 ()
6543-6-040

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Specialty Triathlon Femoral Sizing Feet-Left
Howmedica Osteonics Corp.
I-K3327FS0L
In Commercial Distribution

  • 07613327504309 ()

  • Side: LEFT
I-K3327FS0L

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Specialty Triathlon Femoral Sizing Feet-Right
Howmedica Osteonics Corp.
I-K3327FS0R
In Commercial Distribution

  • 07613327504293 ()

  • Side: RIGHT
I-K3327FS0R

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Hinge Femoral Distal Augment Trial
Howmedica Osteonics Corp.
6543-6-174
In Commercial Distribution

  • 07613327565447 ()

  • Size: 3
  • Thickness: 10.0 Millimeter
  • Size: 4
6543-6-174

  • Knee femur prosthesis trial, reusable
Hinge Femoral Distal Augment Trial
Howmedica Osteonics Corp.
6543-6-171
In Commercial Distribution

  • 07613327565430 ()

  • Size: 1
  • Size: 2
  • Thickness: 10.0 Millimeter
6543-6-171

  • Knee femur prosthesis trial, reusable
Hinge Femoral Trials - Left Tray
Howmedica Osteonics Corp.
6543-6-515
In Commercial Distribution

  • 07613327562644 ()
6543-6-515

  • Instrument tray, reusable
TS Femoral Trials - Right Tray
Howmedica Osteonics Corp.
6543-6-510
In Commercial Distribution

  • 07613327554106 ()
6543-6-510

  • Instrument tray, reusable
TS Femoral Augments Trials Tray
Howmedica Osteonics Corp.
6543-6-508
In Commercial Distribution

  • 07613327551594 ()
6543-6-508

  • Instrument tray, reusable
Fusion Nail Femoral Trial Left
Link Bio Corp
87-1403
In Commercial Distribution

  • 00810022403044 ()


  • Knee stem prosthesis trial
Fusion Nail Femoral Trial Right
Link Bio Corp
87-1402
In Commercial Distribution

  • 00810022403037 ()


  • Knee stem prosthesis trial
OSF Pediatric Femoral Angiography Drape
O&M HALYARD, INC.
70790
In Commercial Distribution

  • 30680651707902 ()
  • 90680651707904 ()
70790NS

  • Patient surgical drape, single-use, non-sterile
Femoral Angiography with Pouch, Drape
O&M HALYARD, INC.
48783
In Commercial Distribution

  • 90680651487837 ()
  • 30680651487835 ()
48783NS

  • Patient surgical drape, single-use
Moveable Radial Femoral Angiography Drape
O&M HALYARD, INC.
40046
In Commercial Distribution

  • 30680651400469 ()
  • 90680651400461 ()
40046NS

  • Patient surgical drape, single-use, non-sterile
Femoral Angiography Drape with Pouches
O&M HALYARD, INC.
39347
In Commercial Distribution

  • 30680651393471 ()
  • 90680651393473 ()
39347NS

  • Patient surgical drape, single-use, non-sterile
Moveable Radial Femoral Angiography Drape
O&M HALYARD, INC.
35586
In Commercial Distribution

  • 30680651355868 ()
  • 90680651355860 ()
35586NS

  • Patient surgical drape, single-use
Preoperative Template, Femoral Stems Assembly
NEXTSTEP ARTHROPEDIX, LLC
10-90-0000
In Commercial Distribution

  • 00810030811565 ()


  • Surgical implant template, reusable
Femoral Head, 40mm, +8mm, Ceramic
NEXTSTEP ARTHROPEDIX, LLC
10-24-4003
In Commercial Distribution

  • 00810030810308 ()


  • Ceramic femoral head prosthesis
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