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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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Unigraft is made of synthetic bioactive glass material. The product is conveniently packaged in a sterile vial and stored within a hermetically sealed foil pouch to ensure product sterility prior to implantation. Unigraft offers an osteogenic framework for new bone growth and bolsters a higher level of osteoblastic activity to enhance bone regeneration. FDA has cleared this product for use in treating periodontal defects, extractions sites, sinus elevation, apicoectomy and root resection, cranial and facial augmentation and augmentation of the alveolar ridges.
UNICARE BIOMEDICAL INC.
200-400um 0.4g
In Commercial Distribution

  • D767U0101051 ()
  • D767U010101 ()
U01-0105

  • Synthetic bone graft
BenaCel® Plus Hemostatic Dressing is provided in larger sizes for medical use. Made of biocompatible oxidized cellulose, BenaCel® Plus is intended for the temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, donor sites, dermatological, etc.) and traumatic injuries. It may also be used as a topical dressing for local management of bleeding wounds such as lacerations, cuts and abrasions. Approximate resorption time is 2 weeks.
UNICARE BIOMEDICAL INC.
10x20mm
In Commercial Distribution

  • D767B0226101 ()
  • D767B0226100 ()
B02-2610

  • Plant polysaccharide haemostatic agent, bioabsorbable
BenaCel® Plus Hemostatic Dressing is provided in larger sizes for medical use. Made of biocompatible oxidized cellulose, BenaCel® Plus is intended for the temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, donor sites, dermatological, etc.) and traumatic injuries. It may also be used as a topical dressing for local management of bleeding wounds such as lacerations, cuts and abrasions. Approximate resorption time is 2 weeks.
UNICARE BIOMEDICAL INC.
10x15mm
In Commercial Distribution

  • D767B0224101 ()
  • D767B0224100 ()
B02-2410

  • Plant polysaccharide haemostatic agent, bioabsorbable
BenaCel® Plus Hemostatic Dressing is provided in larger sizes for medical use. Made of biocompatible oxidized cellulose, BenaCel® Plus is intended for the temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, donor sites, dermatological, etc.) and traumatic injuries. It may also be used as a topical dressing for local management of bleeding wounds such as lacerations, cuts and abrasions. Approximate resorption time is 2 weeks.
UNICARE BIOMEDICAL INC.
10x10cm
In Commercial Distribution

  • D767B0222101 ()
  • D767B0222100 ()
B02-2210

  • Plant polysaccharide haemostatic agent, bioabsorbable
BenaCel® Plus Hemostatic Dressing is provided in larger sizes for medical use. Made of biocompatible oxidized cellulose, BenaCel® Plus is intended for the temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, donor sites, dermatological, etc.) and traumatic injuries. It may also be used as a topical dressing for local management of bleeding wounds such as lacerations, cuts and abrasions. Approximate resorption time is 2 weeks.
UNICARE BIOMEDICAL INC.
5x20cm
In Commercial Distribution

  • D767B0214101 ()
  • D767B0214100 ()
B02-1410

  • Plant polysaccharide haemostatic agent, bioabsorbable
BenaCel® Plus Hemostatic Dressing is provided in larger sizes for medical use. Made of biocompatible oxidized cellulose, BenaCel® Plus is intended for the temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, donor sites, dermatological, etc.) and traumatic injuries. It may also be used as a topical dressing for local management of bleeding wounds such as lacerations, cuts and abrasions. Approximate resorption time is 2 weeks.
UNICARE BIOMEDICAL INC.
5x10cm
In Commercial Distribution

  • D767B0210101 ()
  • D767B0210100 ()
B02-1010

  • Plant polysaccharide haemostatic agent, bioabsorbable
BenaCel® Plus Hemostatic Dressing is provided in larger sizes for medical use. Made of biocompatible oxidized cellulose, BenaCel® Plus is intended for the temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, donor sites, dermatological, etc.) and traumatic injuries. It may also be used as a topical dressing for local management of bleeding wounds such as lacerations, cuts and abrasions. Approximate resorption time is 2 weeks.
UNICARE BIOMEDICAL INC.
5x5cm
In Commercial Distribution

  • D767B0205101 ()
  • D767B0205100 ()
B02-0510

  • Plant polysaccharide haemostatic agent, bioabsorbable
1.5 mm x 8.0 mm self-tapping titanium alloy bone fixation screw
Osteogenics Biomedical Inc
PFB8-5
In Commercial Distribution

  • D765PFB850 ()
  • D765PFB851 ()

  • Length: 8.0 Millimeter


  • Craniofacial bone screw, non-bioabsorbable
1.5 mm x 14.0 mm self-tapping titanium alloy bone fixation screw
Osteogenics Biomedical Inc
PFB14-5
In Commercial Distribution

  • D765PFB1450 ()
  • D765PFB1451 ()

  • Length: 14.0 Millimeter


  • Craniofacial bone screw, non-bioabsorbable
1.5 mm x 12.0 mm self-tapping titanium alloy bone fixation screw
Osteogenics Biomedical Inc
PFB12-5
In Commercial Distribution

  • D765PFB1250 ()
  • D765PFB1251 ()

  • Length: 12.0 Millimeter


  • Craniofacial bone screw, non-bioabsorbable
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