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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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Analogue and Strengthener Replicating Cut TSA6 Abutment
SOUTHERN IMPLANTS (PTY) LTD
LT6-7/10
In Commercial Distribution

  • 06009544015895 ()


  • Dental implant analog
V.A.C. DRAPE
KCI USA, INC.
M6275009/10
In Commercial Distribution

  • 00878237001646 ()
  • 00878237001479 ()


  • Negative-pressure wound therapy system drape
Sensatrac Pad
KCI USA, INC.
M8275057/10
In Commercial Distribution

  • 00878237001141 ()
  • 00878237001134 ()


  • Negative-pressure wound therapy tubing set
ARTSMedia In Vitro Culture Medium is a culture medium intended for in vitro fertilization and in vitro culture of human gametes and embryos from fertilization until the blastocyst stage of development (day 5). The medium can also be used for embryo transfer.
Artsmedia Denmark ApS
10 mL
In Commercial Distribution

  • 05745000591015 ()
501010

  • IVF medium
A non-sterile substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused.
AMERICAN DENTAL PRODUCTS INC
10 ml
Not in Commercial Distribution

  • 00865849000242 ()

  • Total Volume: 10 Milliliter
9515140

  • Dental coating, tooth-desensitizing
A non-sterile substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused.
AMERICAN DENTAL PRODUCTS INC
10 ml
Not in Commercial Distribution

  • 00865849000228 ()

  • Total Volume: 10 Milliliter
9515140

  • Dental coating, tooth-desensitizing
Non-Latex Polyisoprene Balloons (600cc) 10 Pack
H & A Mui Enterprises Inc
CBL7P(10)
In Commercial Distribution

  • 00678467006196 ()


  • Gastrointestinal motility manometric catheter, non-electronic
Non-Latex Polyisoprene Balloons (400cc) 10 Pack
H & A Mui Enterprises Inc
CBS6P(10)
In Commercial Distribution

  • 00678467005878 ()


  • Gastrointestinal motility manometric catheter, non-electronic
Clear TPE Balloons (400cc) 10 Pack
H & A Mui Enterprises Inc
CBS6T(10)
In Commercial Distribution

  • 00678467005779 ()


  • Gastrointestinal motility manometric catheter, non-electronic
Clear TPE Powdered Balloon 10 Pack
H & A Mui Enterprises Inc
BS6TU(10)
In Commercial Distribution

  • 00678467005359 ()


  • Gastrointestinal motility manometric catheter, non-electronic
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