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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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Hobbs Biliary Pigtail Stent - M84961020

A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It is made entirely of a synthetic polymer with drainage side ports. This is a single-use device.
HOBBS MEDICAL, INC.
6102
In Commercial Distribution

  • M84961020 ()
6102

  • Polymeric biliary stent, non-bioabsorbable

Self Etching Primer - D798SEPD0

The Reliance S.E.P.™ is a self etching primer dispenser is intended to be used for the delivery of the primer in preparation of an enamel surface of a tooth prior to bonding with a light cure orthodontic adhesive.
RELIANCE ORTHODONTIC PRODUCTS INC
SEPD
In Commercial Distribution

  • D798SEPD0 ()
SEPD

  • Dental etching solution

Chartis Console - M776CHRCO100

The Pulmonx® Chartis System is designed to measure pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments. The Chartis Console has a touch-screen user interface that is easy to navigate, and a mouse or keyboard is not required. Patient assessment data can be exported to a USB flash memory device.
PULMONX CORPORATION
G3
In Commercial Distribution

  • M776CHRCO100 ()
CHR-CO-100

  • Diagnostic spirometer, professional

Microlyte Matrix - 00860001725735

Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sqin. Microlyte® Matrix is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.
IMBED BIOSCIENCES, INC.
91002
In Commercial Distribution

  • 00860001725735 ()
  • B519910020 ()
  • 00860001725728 ()

  • Area/Surface Area: 100 Square centimeter


  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial

Microlyte Matrix - 00860001725711

Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sqin. Microlyte® Matrix is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.
IMBED BIOSCIENCES, INC.
91001
In Commercial Distribution

  • 00860001725711 ()
  • B519910010 ()
  • 00860001725704 ()

  • Area/Surface Area: 25 Square centimeter


  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial

MapperFrame - EFIAA0127041

The product MapperFrame supports the Automatic Registration process for image guided surgery procedures with the Fiagon Navigation System. The MapperFrame is a reusable device. It can be used with a surgical sterile drape in the operating area. The MapperFrame is improper for treatment by autoclave or other sterilization procedures. The MapperFrame is intended to be used in connection with the iPad Remote Control.
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAA0127041 ()


  • Multi-purpose stereotactic surgery system

Enhance - D798EBAB60

Enhance™is intended for use with any chemical cure, light cure or dual cure adhesive or band cement to increase adhesion to fluorosed, hypocalcified, deciduous enamel or dentin; acrylic, composite or metal surfaces; any enamel surface where maximum adhesion is required; enamel that is close to the gingiva where minor surface moisture may reduce bond strength 6cc Enhance Adhesion Booster Part B
RELIANCE ORTHODONTIC PRODUCTS INC
EBAB6
In Commercial Distribution

  • D798EBAB60 ()
EBAB6

  • Dentine bonding agent/set

Enhance - D798EBAB0

Enhance™is intended for use with any chemical cure, light cure or dual cure adhesive or band cement to increase adhesion to fluorosed, hypocalcified, deciduous enamel or dentin; acrylic, composite or metal surfaces; any enamel surface where maximum adhesion is required; enamel that is close to the gingiva where minor surface moisture may reduce bond strength 3cc Enhance Adhesion Booster Part B
RELIANCE ORTHODONTIC PRODUCTS INC
EBAB
In Commercial Distribution

  • D798EBAB0 ()
EBAB

  • Dentine bonding agent/set

Enhance - D798EBAA60

Enhance™is intended for use with any chemical cure, light cure or dual cure adhesive or band cement to increase adhesion to fluorosed, hypocalcified, deciduous enamel or dentin; acrylic, composite or metal surfaces; any enamel surface where maximum adhesion is required; enamel that is close to the gingiva where minor surface moisture may reduce bond strength 6cc Enhance Adhesion Booster Part A.
RELIANCE ORTHODONTIC PRODUCTS INC
EBAA6
In Commercial Distribution

  • D798EBAA60 ()
EBAA6

  • Dentine bonding agent/set

TAUB - Trident - IMPULSE - D8379910360

This is a chisel tip for removing cemented crowns off a tooth or implant abutment. The IMPULSE is a hand held and operated crown remover. It is a spring loaded device with 3 power settings. The IMPULSE provides a shock "Pulse" to the restoration to break the seal of the cement and allows the restoration to be removed with certain cements.
Taub Products
Tips - Single Crown (Chisel edge) - Polished
In Commercial Distribution

  • D8379910360 ()
99-1036

  • Dental prosthesis removal instrument
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