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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LIT 33TH40L DYSTONIA EMANUALS EN
MEDTRONIC, INC.
33TH40L
In Commercial Distribution

  • 00763000810535 ()


  • Deep brain electrical stimulation system
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
S.R. MCP INSTRUMENT SET, PHALANGEAL IMPACTOR
Stryker GmbH
17-1538
In Commercial Distribution

  • 00886385020976 ()


  • Orthopaedic implant driver
S.R. MCP INSTRUMENT SET, METACARPAL IMPACTOR
Stryker GmbH
17-1537
In Commercial Distribution

  • 00886385020969 ()


  • Orthopaedic implant driver
SR PIP INSTRUMENT SET, DISTAL IMPACTOR
Stryker GmbH
17-1354
In Commercial Distribution

  • 00886385020075 ()


  • Orthopaedic implant driver
PIP PROXIMAL IMPACTOR ASSEMBLY
Stryker GmbH
17-1353
In Commercial Distribution

  • 00886385020068 ()


  • Orthopaedic implant driver
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