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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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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
TendoNova Disposable Unit 60mm Kit-Single
Tendonova Corporation
DU1F60L-K
In Commercial Distribution

  • 00860009899865 ()

  • Length: 60 Millimeter


  • Skin topical coupling gel
  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
  • Skin-cover adhesive strip, non-antimicrobial
  • Patient surgical drape, single-use
  • Orthopaedic implant aiming arm
Tempo Insights™ is the healthcare provider-facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers. TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.1
In Commercial Distribution

  • B553TEMPOINSIGHTS110 ()


  • Home pharmaceutical management support software
Tempo Insights™ is the healthcare provider-facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers. TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.0
Not in Commercial Distribution

  • B553TEMPOINSIGHTS100 ()


  • Home pharmaceutical management support software
Wound Cleanser No-rinse, non-irritating formulation Non-ionic surfactant Directions for use: 1. Turn nozzle to stream or spray position. 2. Spray contents on area to be cleansed approximately 3 inches away. Ingredients: Purified water, poloxamer 188, sodium bicarbonate, sorbitol, citric acid, disodium EDTA, methylparaben, imidazolidinyl urea Indications: May be used for the removal of foreign materials such as dirt and debris from dermal wounds. Caution: For external use only. Keep this and all similar products out of the reach of children. Store at ambient temperature.
Cardinal Health 200, LLC
WC8OZ
In Commercial Distribution

  • 10888499001343 ()
  • 00888499001346 ()
  • 00885380171867 ()
WC8OZ

  • Skin detergent
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
AquaSeal Water-Blocking Reusable Earplugs with Carrying Case, 2-Pairs Howard Leight by Honeywell AquaSeal Water-Blocking Reusable Earplugs are specially designed to help prevent swimmer's ear. Using a triple flange design, these earplugs create a series of low-pressure air pocket seals inside your ear canal. The result is a comfortable, water-resistant earplug that's soft on your inner ear. Insertion and removal are easy thanks to the convenient outer handle. This package comes with a convenient carrying case for easy storage in the boat, on the dock, or in your pocket. 2 pairs of earplugs per pack
SPERIAN HEARING PROTECTION, LLC
AquaSeal
In Commercial Distribution

  • 00033552016847 ()
R-01684

  • Earplugs, single-use
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