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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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Stimulan® Calcium Sulfate Bone Void Filler pellets are provided sterile for single patient use. The biodegradable, radiopaque pellets are resorbed in approximately 30-60 days when used in accordance with the device labelling. Calcium Sulfate Bone Filler is manufactured from medical grade calcium sulfate dihydrate (CaSO4 2H20) and stearic acid that resorbs and is replaced with bone during the healing process. Also as the bone void filler pellets are biodegradable and biocompatible, they may be used at an infected site.
BIOCOMPOSITES LTD
600-48-010
In Commercial Distribution


  • 10cc
  • Width: 4.8 Millimeter
600-48-010

  • Synthetic bone graft
Stimulan® Calcium Sulfate Bone Void Filler pellets are provided sterile for single patient use. The biodegradable, radiopaque pellets are resorbed in approximately 30-60 days when used in accordance with the device labelling. Calcium Sulfate Bone Filler is manufactured from medical grade calcium sulfate dihydrate (CaSO4 2H20) and stearic acid that resorbs and is replaced with bone during the healing process. Also as the bone void filler pellets are biodegradable and biocompatible, they may be used at an infected site.
BIOCOMPOSITES LTD
600-30-005
In Commercial Distribution


  • Width: 3 Millimeter
  • 5cc
600-30-005

  • Synthetic bone graft
Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is provided sterile for single patient use. The biodegradable, radiopaque granules/blocks are resorbed in approximately 6-12 months when used in accordance with the device labelling. Biocomposites Tri-Calcium Phosphate Bone Graft Substitute is manufactured from medical grade Tri-Calcium Phosphate. Numerous bone graft operations are undertaken every year to repair bone defects caused by surgery, tumours, trauma, infections and other damage. Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is intended for use in clinical situations where the use of autologous grafts or other bone graft substitutes maybe undesirable, due either to the risk of associated infection or unavailability. Allogran-R® resorbs and is replaced with bone during the healing process.
BIOCOMPOSITES LTD
800-010
In Commercial Distribution


  • 10cc
800-010

  • Synthetic bone graft
Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is provided sterile for single patient use. The biodegradable, radiopaque granules/blocks are resorbed in approximately 6-12 months when used in accordance with the device labelling. Biocomposites Tri-Calcium Phosphate Bone Graft Substitute is manufactured from medical grade Tri-Calcium Phosphate. Numerous bone graft operations are undertaken every year to repair bone defects caused by surgery, tumours, trauma, infections and other damage. Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is intended for use in clinical situations where the use of autologous grafts or other bone graft substitutes maybe undesirable, due either to the risk of associated infection or unavailability. Allogran-R® resorbs and is replaced with bone during the healing process.
BIOCOMPOSITES LTD
800-005
In Commercial Distribution


  • 5cc
800-005

  • Synthetic bone graft
Single Patient Use Filshie® Clip Application Kit for Minilaparotomy. Includes one Sterishot Minilap Applicator and one pair of Filshie® Clips.
FEMCARE LIMITED
AVM-951M
In Commercial Distribution

  • 15055515602197 ()
  • 45055515602358 ()
  • 15055515602357 ()
AVM-951M

  • Fallopian tube clip/band
Single Patient Use Filshie® Clip Application Kit for Dual Incision Laparoscopy. Includes one Sterishot II Applicator and one pair of Filshie® Clips.
FEMCARE LIMITED
AVM-951
In Commercial Distribution

  • 15055515602180 ()
  • 55055515602331 ()
  • 15055515602333 ()
  • 45055515602334 ()
AVM-951

  • Fallopian tube clip/band
Reusable Filshie Clip Applicators for single incision laparoscopy
FEMCARE LIMITED
AVM-880
In Commercial Distribution

AVM-880

  • Fallopian tube clip/band
Reusable Filshie Clip Applicator for dual incision laparoscopy
FEMCARE LIMITED
AVM-863
In Commercial Distribution

AVM-863

  • Fallopian tube clip/band
Reusable Filshie Clip Applicator for single incision laparoscopy
FEMCARE LIMITED
AVM-857
In Commercial Distribution

AVM-857

  • Fallopian tube clip/band
Reusable Filshie Clip Applicator for Minilaparotomy
FEMCARE LIMITED
AVM-856
In Commercial Distribution

AVM-856

  • Fallopian tube clip/band
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