SEARCH RESULTS FOR: (*One Satoshitg:(@hkotccc)tFIg*)(61 results)

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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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DBX® - W4184028050T0476

DBX Paste, 5cc
Musculoskeletal Transplant Foundation, Inc.
028050
In Commercial Distribution

  • W4184028050T0476 ()

  • 5 cc volume
028050

  • Bone matrix implant, human-derived

DBX® - W4184028010T0476

DBX Paste, 1cc
Musculoskeletal Transplant Foundation, Inc.
028010
In Commercial Distribution

  • W4184028010T0476 ()

  • 1.0 cc volume
028010

  • Bone matrix implant, human-derived

DBX® - W4184028005T0476

DBX Paste, 0.5cc
Musculoskeletal Transplant Foundation, Inc.
028005
In Commercial Distribution

  • W4184028005T0476 ()
028005

  • Bone matrix implant, human-derived

Trabexus® - W4146EB0010T0475

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

Trabexus® - W4146EB0005T0475

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

Trabexus® - W4146EB0003T0475

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) - W41020AU201S1969

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) - 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

Two Stage Bone Level Implant - D78532508ENGPLS0

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

QUALA - Q023QEP231

QUALA PERIOSTEAL SELDIN 23
NATIONAL DISTRIBUTION & CONTRACTING, INC.
QEP23
In Commercial Distribution

  • Q023QEP231 ()
QEP23

  • Periosteal elevator, reusable
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