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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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This product is intended to be used in combination with an endoscope to assist endoscopic insertion into the body. Never use this product for any other purpose. This product is intended for use in medical facilities by medical professionals who are properly trained in using it as well as in endoscopic procedures and endoscopic treatments.
FUJIFILM CORPORATION
TR-1108A
In Commercial Distribution

  • 04547410543858 ()
  • 14547410543855 ()


  • Endoscopic overtube, single-use
This product is intended to be used in combination with an endoscope to assist endoscopic insertion into the body. Never use this product for any other purpose. This product is intended for use in medical facilities by medical professionals who are properly trained in using it as well as in endoscopic procedures and endoscopic treatments.
FUJIFILM CORPORATION
TR-1504A
In Commercial Distribution

  • 14547410484745 ()
  • 04547410484748 ()


  • Endoscopic overtube, single-use
This product is intended to be used in combination with an endoscope to assist endoscopic insertion into the body. Never use this product for any other purpose. This product is intended for use in medical facilities by medical professionals who are properly trained in using it as well as in endoscopic procedures and endoscopic treatments.
FUJIFILM CORPORATION
TR-1507A
In Commercial Distribution

  • 14547410484714 ()
  • 04547410484717 ()


  • Endoscopic overtube, single-use
This product is intended to be used in combination with an endoscope to assist endoscopic insertion into the body. Never use this product for any other purpose. This product is intended for use in medical facilities by medical professionals who are properly trained in using it as well as in endoscopic procedures and endoscopic treatments.
FUJIFILM CORPORATION
TR-1208A
In Commercial Distribution

  • 14547410484684 ()
  • 04547410484687 ()


  • Endoscopic overtube, single-use
Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 2 cc suspended in a biocompatible hydrogel solution packed in a 14ml open bore syringe. They are packed in a vacuum-sealed foil inner pouch within a Tyvek outer pouch and packed in a carton box. Animal Only
BIOSTONE CO. LIMITED
VET1210-O
In Commercial Distribution

  • 05060548020163 ()
VET1210-O

  • Bone matrix implant, synthetic, non-antimicrobial
Silica-induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 5 cc suspended in a biocompatible hydrogel solution packed in a 14ml open bore syringe. They are packed in a vacuum-sealed foil inner pouch within a Tyvek outer pouch and packed in a carton box. Animal use only
BIOSTONE CO. LIMITED
VET1205-O
In Commercial Distribution

  • 05060548020156 ()
VET1205-O

  • Bone matrix implant, synthetic, non-antimicrobial
Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 3 cc suspended in a biocompatible hydrogel solution packed in a 14ml open bore syringe. They are packed in a vacuum-sealed foil inner pouch within a Tyvek outer pouch and packed in a carton box. Animal use only
BIOSTONE CO. LIMITED
VET1203-O
In Commercial Distribution

  • 05060548020149 ()
VET1203-O

  • Bone matrix implant, synthetic, non-antimicrobial
The Prismaflex TPE2000 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered), after having selected TPE therapy. The Prismaflex TPE2000 set is intended for use in therapeutic plasma exchange, thus in diseases where removal of plasma components in indicated.
GAMBRO INDUSTRIES
114093
In Commercial Distribution

  • 07332414111038 ()
  • 37332414111039 ()
114093

  • Apheresis system filter, whole blood
The VersaWrap wetting Solution is applied to the Sheet to render the Sheet a gelatinous, tissue adherent layer (gel in situ). The aqueous citrate Solution is provided sterile, non-pyrogenic, for single use, in a dropper, packaged in a double peel pouch.
Alafair Biosciences, Inc.
VSC-1
In Commercial Distribution

  • B454VSC10 ()
VSC-1

  • Nerve guide, synthetic polymer, bioabsorbable
  • Tendon spacer
Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL syringe is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen. It is a viscous solution of purified natural Sodium Hylauronate (Hyalectin®) in buffered physiological sodium chloride. The sodium hylauronate is extracted from rooster combs. It is given by intra-articular injection in a treatment cycle consisting of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly cycles. This has been noted in studies reported in the literature in which patients treated with three injections were followed for 60 days.
FIDIA FARMACEUTICI SPA
89122-0724-20
Not in Commercial Distribution

  • M71389122072420A1 ()
89122-0724-20

  • Synovial fluid supplementation medium
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