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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

Neuroform3 - 07613252193814

Microdelivery Stent System
Stryker Corporation
M003SNF330150
In Commercial Distribution

  • 07613252193814 ()

  • Length: 15.0 Millimeter
  • Outer Diameter: 3.0 Millimeter
M003SNF330150

  • Bare-metal intracranial vascular stent

Neuroform3 - 07613252193807

Microdelivery Stent System
Stryker Corporation
M003SNF325200
In Commercial Distribution

  • 07613252193807 ()

  • Outer Diameter: 2.5 Millimeter
  • Length: 20.0 Millimeter
M003SNF325200

  • Bare-metal intracranial vascular stent

Neuroform3 - 07613252193791

Microdelivery Stent System
Stryker Corporation
M003SNF325150
In Commercial Distribution

  • 07613252193791 ()

  • Length: 15.0 Millimeter
  • Outer Diameter: 2.5 Millimeter
M003SNF325150

  • Bare-metal intracranial vascular stent

NEUROFORM EZ 3 - 07613252193579

Stent System
Stryker Corporation
M003N3EZ45100
In Commercial Distribution

  • 07613252193579 ()

  • Length: 10.0 Millimeter
  • Outer Diameter: 4.5 Millimeter
M003N3EZ45100

  • Bare-metal intracranial vascular stent

NEUROFORM EZ 3 - 07613252193500

Stent System
Stryker Corporation
M003N3EZ35100
In Commercial Distribution

  • 07613252193500 ()

  • Length: 10.0 Millimeter
  • Outer Diameter: 3.5 Millimeter
M003N3EZ35100

  • Bare-metal intracranial vascular stent

Neuroform Stabilizer - 07613252193951

2F Stabilizer Catheter
Stryker Corporation
M003SNF3STA0
In Commercial Distribution

  • 07613252193951 ()

  • Lumen/Inner Diameter: 0.016 Inch
  • Length: 152.0 Centimeter
M003SNF3STA0

  • Vascular microcatheter

Neuroform3 - 07613252193944

Microdelivery Stent System
Stryker Corporation
M003SNF345300
In Commercial Distribution

  • 07613252193944 ()

  • Length: 30.0 Millimeter
  • Outer Diameter: 4.5 Millimeter
M003SNF345300

  • Bare-metal intracranial vascular stent

Neuroform3 - 07613252193937

Microdelivery Stent System
Stryker Corporation
M003SNF345200
In Commercial Distribution

  • 07613252193937 ()

  • Length: 20.0 Millimeter
  • Outer Diameter: 4.5 Millimeter
M003SNF345200

  • Bare-metal intracranial vascular stent
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