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
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-113
In Commercial Distribution

  • 09348215074760 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-112
In Commercial Distribution

  • 09348215074753 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-111
In Commercial Distribution

  • 09348215074746 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-110
In Commercial Distribution

  • 09348215074739 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-109
In Commercial Distribution

  • 09348215074722 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-108
In Commercial Distribution

  • 09348215074715 ()


  • Surgical implant template, reusable
Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures a minimum of 50 cm2 in area. Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
VERICEL CORPORATION
N/A
In Commercial Distribution

  • W41020AU201S1969 ()

  • Area/Surface Area: 50 Square centimeter


  • Cultured skin autograft/xenograft
Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures approximately 50 cm2 in area. Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
VERICEL CORPORATION
0
In Commercial Distribution

  • W41020AU201P0001 ()

  • Area/Surface Area: 50 Square centimeter


  • Cultured skin autograft/xenograft
No Description
CUREXO, Inc.
MW-V100
In Commercial Distribution

  • 08800043810121 ()


  • Treadmill/elliptical gait rehabilitation system
MW-S200
CUREXO, Inc.
MW-S200
In Commercial Distribution

  • 08800043810022 ()
AC-00000-000

  • Treadmill/elliptical gait rehabilitation system
Walking Harness - XXLarge - Orange Binding - 4 Loop - Tricot Material - Reuseable
1073849 Ontario Limited
TSC015WSXXX
In Commercial Distribution

  • 00817956023126 ()

  • Height: 21 Inch
  • Width: 16 Inch
  • Depth: 4 Inch


  • Gait rehabilitation system harness
Walking Harness - XLarge - Blue Binding - 4 Loop - Tricot Material - Reuseable
1073849 Ontario Limited
TSC015WSXX
In Commercial Distribution

  • 00817956023119 ()

  • Height: 21 Inch
  • Width: 16 Inch
  • Depth: 4 Inch


  • Gait rehabilitation system harness
Walking Harness - Large - Green Binding - 4 Loop - Tricot Material - Reuseable
1073849 Ontario Limited
TSC015WSX
In Commercial Distribution

  • 00817956023102 ()

  • Height: 21 Inch
  • Width: 16 Inch
  • Depth: 4 Inch


  • Gait rehabilitation system harness
Walking Harness - Medium - Yellow Binding - 4 Loop - Tricot Material - Reuseable
1073849 Ontario Limited
TSC015WS
In Commercial Distribution

  • 00817956023096 ()

  • Height: 21 Inch
  • Width: 17 Inch
  • Depth: 4 Inch


  • Gait rehabilitation system harness
Walking Harness - Small - Red Binding - 4 Loop - Tricot Material - Reuseable
1073849 Ontario Limited
TSC015WSP
In Commercial Distribution

  • 00817956023089 ()

  • Height: 21 Inch
  • Width: 17 Inch
  • Depth: 4 Inch


  • Gait rehabilitation system harness
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type L-4mm
In Commercial Distribution

  • 07290114063081 ()
190-000117-04

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type J
In Commercial Distribution

  • 07290114063074 ()
190-000117-03

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type G
In Commercial Distribution

  • 07290114063067 ()
190-000117-02

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type B
In Commercial Distribution

  • 07290114063050 ()
190-000117-01

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart NeuroForits Drive Headstage
In Commercial Distribution

  • 07290114062985 ()
700-006010-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega NeuroFortis Drive Headstage
In Commercial Distribution

  • 07290114062510 ()
750-000070-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MER Headstage
In Commercial Distribution

  • 07290114062381 ()
700-005023-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart MER Headstage
In Commercial Distribution

  • 07290114062374 ()
700-006009-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega MER Headstage
In Commercial Distribution

  • 07290114062367 ()
750-000023-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 17290114062319 ()
  • 07290114062312 ()
  • 37290114062313 ()
STR-AP9080-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega Drive Headstage
In Commercial Distribution

  • 07290114062305 ()
750-000020-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-Shielded
In Commercial Distribution

  • 17290114062258 ()
  • 07290114062251 ()
STR-000136-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 17290114062241 ()
  • 07290114062244 ()
STR-001080-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 17290114062234 ()
  • 07290114062237 ()
STR-000081-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-Shielded
In Commercial Distribution

  • 17290114062029 ()
  • 07290114062022 ()
STR-901079-00

  • Depth electrode
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