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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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Epicel (cultured epidermal autografts) - W41020AU201P0001

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

Argus ll Operating Room Coil - 00856264005387

The operating room coil is used during surgery in replacement of the glasses. A telemetry coil and radio-frequency system are mounted on the device to provide communication between the implant and the VPU during surgery.
Second Sight Medical Products, Inc.
012103-003
Not in Commercial Distribution

  • 00856264005387 ()
012103

  • Retinal prosthesis system implantation test coil

NEUROFORM EZ 3 - 04546540697769

Stent System
Stryker Corporation
M003N3EZ30200
In Commercial Distribution

  • 04546540697769 ()

  • Outer Diameter: 3.0 Millimeter
  • Length: 20.0 Millimeter
M003N3EZ30200

  • Bare-metal intracranial vascular stent

NEUROFORM EZ 3 - 04546540697745

Stent System
Stryker Corporation
M003N3EZ25200
In Commercial Distribution

  • 04546540697745 ()

  • Length: 20.0 Millimeter
  • Outer Diameter: 2.5 Millimeter
M003N3EZ25200

  • Bare-metal intracranial vascular stent

Wingspan - 04546540722904

Stent System
Stryker Corporation
M003WS0450200
In Commercial Distribution

  • 04546540722904 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 20.0 Millimeter
M003WS0450200

  • Bare-metal intracranial vascular stent

Wingspan - 04546540722898

Stent System
Stryker Corporation
M003WS0450150
In Commercial Distribution

  • 04546540722898 ()

  • Length: 15.0 Millimeter
  • Outer Diameter: 4.5 Millimeter
M003WS0450150

  • Bare-metal intracranial vascular stent

Wingspan - 04546540722881

Stent System
Stryker Corporation
M003WS0450090
In Commercial Distribution

  • 04546540722881 ()

  • Length: 9.0 Millimeter
  • Outer Diameter: 4.5 Millimeter
M003WS0450090

  • Bare-metal intracranial vascular stent

Wingspan - 04546540722874

Stent System
Stryker Corporation
M003WS0400200
In Commercial Distribution

  • 04546540722874 ()

  • Length: 20.0 Millimeter
  • Outer Diameter: 4.0 Millimeter
M003WS0400200

  • Bare-metal intracranial vascular stent

Wingspan - 04546540722867

Stent System
Stryker Corporation
M003WS0400150
In Commercial Distribution

  • 04546540722867 ()

  • Outer Diameter: 4.0 Millimeter
  • Length: 15.0 Millimeter
M003WS0400150

  • Bare-metal intracranial vascular stent

Wingspan - 04546540722850

Stent System
Stryker Corporation
M003WS0400090
In Commercial Distribution

  • 04546540722850 ()

  • Outer Diameter: 4.0 Millimeter
  • Length: 9.0 Millimeter
M003WS0400090

  • Bare-metal intracranial vascular stent
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