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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Calcium compound bone void filler with DBM (10 cc), previously sold under Trabexus® EB brand name.
Vivorte, Inc
10 cc
In Commercial Distribution

  • W4146EB0010T0475 ()
130703-10

  • Cadaveric-donor/synthetic mineral bone graft
Calcium compound bone void filler with DBM (5cc), Previously sold under Trabexus® EB brand name.
Vivorte, Inc
5 cc
In Commercial Distribution

  • W4146EB0005T0475 ()
130703-05

  • Cadaveric-donor/synthetic mineral bone graft
Calcium compound bone void filler with DBM (3 cc), previously sold under Trabexus® EB brand name.
Vivorte, Inc
3 cc
In Commercial Distribution

  • W4146EB0003T0475 ()
130703-03

  • Cadaveric-donor/synthetic mineral bone graft
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
LayZir isc AD98-25-LZ A2
SMART DENTISTRY SOLUTIONS INC.
CM0034S
In Commercial Distribution

  • D952CM0034 ()
CM0034S

  • Dental appliance fabrication material, ceramic
.016 X .022 NIC-CO-LOY RECTANGULAR 14' LENGHTS (10)
Ortho Arch Company Inc
.016X.022 NIC-CO-LOY LENGHTS
In Commercial Distribution

  • D90922701312C791 ()
227-013

  • Orthodontic archwire
MATHIEU LIGATING PLIER (MEDIUM)
ORTHOPLI CORP.
O12-PM
In Commercial Distribution

  • D917O12PM0 ()
O12-PM

  • Orthodontic pliers
6mm TSI/ERI Indexing Impression Coping 6mm Diameter
OCO BIOMEDICAL INC
6mm TSI/ERI Indexing Impression Coping
In Commercial Distribution

  • D785600IC0 ()
5.0 IC

  • Dental implant abutment impression cap
3.25mm diameter X 8mm length Engage Plus Bone Level Implant
OCO BIOMEDICAL INC
EngagePlus
In Commercial Distribution

  • D78532508ENGPLS0 ()
32508 Engage Plus

  • Screw endosteal dental implant, two-piece
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