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) 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
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D30mm
In Commercial Distribution

  • D960BPX00301 ()
30111610

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D25mm
In Commercial Distribution

  • D960BPX00251 ()
30111608

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D22mm
In Commercial Distribution

  • D960BPX00221 ()
30111606

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D14mm
In Commercial Distribution

  • D960BPX00141 ()
30111602

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D10mm
In Commercial Distribution

  • D960BPX00101 ()
30111600

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D28mm
In Commercial Distribution

  • D960BPX00281 ()
30111609

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D24mm
In Commercial Distribution

  • D960BPX00241 ()
30111607

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D20mm
In Commercial Distribution

  • D960BPX00201 ()
30111605

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D18mm
In Commercial Distribution

  • D960BPX00181 ()
30111604

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D16mm
In Commercial Distribution

  • D960BPX00161 ()
30111603

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D12mm
In Commercial Distribution

  • D960BPX00121 ()
30111601

  • Dental appliance fabrication material, ceramic
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-409
In Commercial Distribution

  • 09348215058098 ()


  • Instrument tray, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-36-0004
In Commercial Distribution

  • 09348215039905 ()


  • Instrument tray, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5016
In Commercial Distribution

  • 09348215087449 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5015
In Commercial Distribution

  • 09348215087432 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5014
In Commercial Distribution

  • 09348215087425 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5013
In Commercial Distribution

  • 09348215087418 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-7050
In Commercial Distribution

  • 09348215087401 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-7040
In Commercial Distribution

  • 09348215087395 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-7030
In Commercial Distribution

  • 09348215087388 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-7020
In Commercial Distribution

  • 09348215087371 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-7010
In Commercial Distribution

  • 09348215087364 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-7000
In Commercial Distribution

  • 09348215087357 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-6050
In Commercial Distribution

  • 09348215087340 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-6040
In Commercial Distribution

  • 09348215087333 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-6030
In Commercial Distribution

  • 09348215087326 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-6020
In Commercial Distribution

  • 09348215087319 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-6010
In Commercial Distribution

  • 09348215087302 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-6000
In Commercial Distribution

  • 09348215087296 ()


  • Orthopaedic broach
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