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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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PuraPly™ Antimicrobial Wound Matrix consists of collagen sheets coated with polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly™ Antimicrobial Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed pouches.
ORGANOGENESIS INC.
515-065
In Commercial Distribution

  • 00618474000435 ()

  • Length: 3 Centimeter
  • Width: 4 Centimeter


  • Collagen wound matrix dressing
PuraPly™ Antimicrobial Wound Matrix consists of collagen sheets coated with polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly™ Antimicrobial Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed pouches.
ORGANOGENESIS INC.
515-069
In Commercial Distribution

  • 00618474000459 ()

  • Width: 4 Centimeter
  • Length: 4 Centimeter


  • Collagen wound matrix dressing
Vashe Wound Solution is a skin, wound, burn cleansing solution that is to be used for debridmement, irrigation, physical disruption of biofilm and removal of microorganisms. This is the 475 ml (16 fl oz) container size with a flip top cap.
URGO MEDICAL NORTH AMERICA, LLC
00314
In Commercial Distribution

  • 10851383003143 ()
  • 00851383003146 ()

  • Total Volume: 475 Milliliter
00314

  • Antimicrobial wound irrigation solution
BIASURGE Advanced Surgical Solution is a clear, colorless solution for use with lavage or preferred application method. The product contains PHMB as a preservative to reduce microbial growth within the packaging during shelf storage after the sterile seal has been broken.
Sanara Medtech Inc.
BAS-0101
In Commercial Distribution

  • 00850017274006 ()
  • 10850017274003 ()


  • Antimicrobial wound irrigation solution
HairCheck-DT (PCP) is an ELISA test kit used for qualitative detection of phencyclidine in head hair with a cutoff of 300 pg/mg of hair. Kit is comprised of 4 component packages: Microplates, Conjugate Reagents, Common Reagents, and Calibrator/Controls.
Quest Diagnostics
K042726
Not in Commercial Distribution

  • 00868586000254 ()


  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
Needle Stimulator is combined with modern micro computer high-new technique, traditional Chinese medicine acupuncture and meridian theory,based on the traditional electronic acupuncture treatment instrument. The product is used for applying low frequency pulse to stimulate the acupoints of human body.
Wuxi Jiajian Medical Instrument Co.,Ltd.
CMNS2-1
In Commercial Distribution

  • 08150050225006 ()


  • Migraine-therapy peripheral nerve electrical stimulator
Needle Stimulator is combined with modern micro computer high-new technique, traditional Chinese medicine acupuncture and meridian theory,based on the traditional electronic acupuncture treatment instrument. The product is used for applying low frequency pulse to stimulate the acupoints of human body.
Wuxi Jiajian Medical Instrument Co.,Ltd.
CMNS6-1
In Commercial Distribution

  • 10815005022400 ()


  • Migraine-therapy peripheral nerve electrical stimulator
A non-adhesive, non-occlusive, antimicrobial absorbent dressing composed of 1) a polyester mesh impregnated with a matrix comprising of hydrocolloid particle (carboxymethylcellulose), cohesiopolymers, petrolatum and silver sulfate, 2) a non-sensitizing, super absorbent polyurethane foam pad, 3) a protective, semi-permeable polyurethane foam backing.
URGO MEDICAL NORTH AMERICA, LLC
509346
In Commercial Distribution

  • 10190769093461 ()
  • 00190769093464 ()

  • 6 X 8 inches
509346

  • Wound-nonadherent dressing, absorbent, antimicrobial
A non-adhesive, non-occlusive, antimicrobial absorbent dressing composed of 1) a polyester mesh impregnated with a matrix comprising of hydrocolloid particle (carboxymethylcellulose), cohesiopolymers, petrolatum and silver sulfate, 2) a non-sensitizing, super absorbent polyurethane foam pad, 3) a protective, semi-permeable polyurethane foam backing.
URGO MEDICAL NORTH AMERICA, LLC
509345
In Commercial Distribution

  • 10190769093454 ()
  • 00190769093457 ()

  • 4 X 4 inches
509345

  • Wound-nonadherent dressing, absorbent, antimicrobial
Gibson Healthcare Endo Irrigation Multi-Canal Kit. Contains: (2) 10ml pre-filled sodium hypochlorite syringe, (1) 9ml pre-filled EDTA syringe, (1) 9ml pre-filled 95% ethyl alcohol syringe, (1) 9ml pre-filled chlorhexidine syringe, (5) 30g irrigation needle tips, (1) canal aspirator with tip.
BENCO DENTAL SUPPLY CO.
5126-310
In Commercial Distribution

  • 10366975032826 ()
  • 00366975032829 ()


  • Root canal cleaning solution
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