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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EUSOL-C is a low salt, vitamin, amino acid, and glucose-enriched iso-osmolar corneal culture balanced medium with sodium piruvate as an ATP precursor and dextran as a deturgescent agent. It is supplemented with 143 ug/ml gentamicin sulfate. It has sodium bicarbonate and Hepes buffers to maintain pH in the range of 7.2 – 7.6 and Phenol red as a pH indicator. EUSOL-C is for storage of donor corneas at 2°C – 8°C for up to 14 days. It provides basic nutrients for cell maintenance and prevents tissue swelling preserving corneal thickness.
AL.CHI.MI.A. SRL
CSM 001-00
In Commercial Distribution

  • 18021118000590 ()
  • 08021118000593 ()

  • Total Volume: 20 Milliliter


  • Corneal storage medium
Non-sterile, non-implantable wound dressing
Keranetics, Inc.
00
In Commercial Distribution

  • B789P00211 ()
  • B789P00210 ()

  • Total Volume: 5 Milliliter


  • Skin semi-occlusive dressing, non-antimicrobial
Sterile, non-implantable, water-based gelatinous (hydrogel) wound dressing
Keranetics, Inc.
00
In Commercial Distribution

  • B789P00100 ()
  • B789P00101 ()

  • Total Volume: 5 Milliliter


  • Wound hydrogel dressing, non-antimicrobial
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
BenaCel® dental dressing is made of biocompatible oxidized cellulose and contains no chemical additives. BenaCel® dental dressing adheres to moist oral mucosa and forms a temporary barrier protecting the wound from further irritation and pain. When placed in the extraction socket, BenaCel® dental dressing forms a gelatinous scaffold in the blood extrude, facilitating the development of a stable blood clot to prevent dry socket formation. BenaCel® dental dressing is designed for use in the extraction site and the management of bleeding and alveolar osteitis (dry socket). It may also be used as a wound dressing for the temporary management of oral surgical wounds, such as operative, postoperative, donor sites and traumatic injuries.
UNICARE BIOMEDICAL INC.
C-004
In Commercial Distribution

  • D767B0105081 ()
  • D767B0104081 ()
B01-0408

  • General oral wound dressing, non-animal-derived, sterile
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