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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For use in obturating root canals as part of orthograde root canal therapy with gutta percha.
NUSMILE, LTD.
SANSMK
In Commercial Distribution

  • 00810118103964 ()

  • Weight: 0.5 Gram


  • Hygroscopic dental cement
For use in obturating root canals as part of orthograde root canal therapy with gutta percha.
NUSMILE, LTD.
SANSIMK
In Commercial Distribution

  • 00810118103902 ()

  • Weight: 0.5 Gram


  • Hygroscopic dental cement
A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buckling for the surgical treatment of retinal detachment. It is typically a moulded solid silicone or silicone sponge device available in a variety of shapes and sizes that is used to compress the retina long-term (up to months) to support its reattachment following the operative treatment of severe retinal detachment. This device, also known as a scleral buckling component, will occupy the intraocular space to provide compression against the retina so that it can reattach. It is typically removed after a period of time depending upon the clinical findings.
FCI S A S FCI 20 22
GROOVED SPONGE 7.5 x 3.5 TYPE 509 G
In Commercial Distribution

  • 53760087122003 ()
  • 03760087122008 ()

  • Length: 100 Millimeter
  • Width: 7.4 Millimeter
  • Height: 3.5 Millimeter
S5.6570U

  • Scleral buckling device, non-bioabsorbable
A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buckling for the surgical treatment of retinal detachment. It is typically a moulded solid silicone or silicone sponge device available in a variety of shapes and sizes that is used to compress the retina long-term (up to months) to support its reattachment following the operative treatment of severe retinal detachment. This device, also known as a scleral buckling component, will occupy the intraocular space to provide compression against the retina so that it can reattach. It is typically removed after a period of time depending upon the clinical findings.
FCI S A S FCI 20 22
GROOVED SPONGE Ø 5 mm TYPE 505 G
In Commercial Distribution

  • 53760087121983 ()
  • 03760087121988 ()

  • Length: 100 Millimeter
  • Outer Diameter: 5 Millimeter
S5.6520U

  • Scleral buckling device, non-bioabsorbable
A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buckling for the surgical treatment of retinal detachment. It is typically a moulded solid silicone or silicone sponge device available in a variety of shapes and sizes that is used to compress the retina long-term (up to months) to support its reattachment following the operative treatment of severe retinal detachment. This device, also known as a scleral buckling component, will occupy the intraocular space to provide compression against the retina so that it can reattach. It is typically removed after a period of time depending upon the clinical findings.
FCI S A S FCI 20 22
GROOVED SPONGE 5.5 x 7.5 TYPE 507 G
In Commercial Distribution

  • 53760087121907 ()
  • 03760087121902 ()

  • Length: 100 Millimeter
  • Width: 7.5 Millimeter
  • Height: 5.5 Millimeter
S5.6560U

  • Scleral buckling device, non-bioabsorbable
A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buckling for the surgical treatment of retinal detachment. It is typically a moulded solid silicone or silicone sponge device available in a variety of shapes and sizes that is used to compress the retina long-term (up to months) to support its reattachment following the operative treatment of severe retinal detachment. This device, also known as a scleral buckling component, will occupy the intraocular space to provide compression against the retina so that it can reattach. It is typically removed after a period of time depending upon the clinical findings.
FCI S A S FCI 20 22
GROOVED SPONGE 3 x 5 TYPE 506 G
In Commercial Distribution

  • 53760087121877 ()
  • 03760087121872 ()

  • Length: 100 Millimeter
  • Width: 5 Millimeter
  • Height: 3 Millimeter
S5.6540U

  • Scleral buckling device, non-bioabsorbable
IPS e.max Ceram Transpa Incisal 20 g 1, IPS e.max Press LT A2 5 Stk., IPS e.max Press HT A2 5 Stk., IPS e.max Press Multi A2 5 Stk., IPS Ivocolor Essence 1.8g E04 sunset, IPS Ivocolor Shade Dentin 3g SD2, IPS Ivocolor Shade Incisal 3g SI1, IPS Ivocolor Glaze Powder FLUO 1.8g, IPS Ivocolor Mix Liq allround 15ml, IPS e.max Press MT A2 5 Stk.
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
745006EN
Not in Commercial Distribution

  • DIVO745006EN0 ()
  • DIVO745006EN1 ()
745006EN

  • Dental implant suprastructure, permanent, preformed
As packaged, NEOVEIL is a suture- and staple-reinforcement product composed of 100% bioabsorbable polyglycolic acid (PGA). This nonwoven product is dyed with D&C Green No.6 in order to make it readily visible to the surgeon. Two forms of NEOVEIL are provided. The Tube type model constitutes of pre-formed porous bio-absorbable nonwoven sheets and is intended for staple-line reinforcement. The Tube type model is provided in the form of sleeves, one for the cartridge and one for the anvil on a corresponding stapler. After deployment of the tube type reinforcement material, the non-degradable elastic knits, comprised of polyurethane and nylon, are removed and discarded along with the PGA tacking sutures. The Sheet type model is simply a porous fibrous bio-absorbable sheet which is intended for suture-line reinforcement. The thickness of the bioabsorbable NEOVEIL staple line reinforcement ranges from 0.1 mm to 0.85 mm. Mesh weave characteristics and pore size are not applicable since NEOVEIL is nonwoven material. Average basis weight of the NEOVEIL model ranges from 35 to 225 (g/m2).
GUNZE LIMITED
NV-ET-M60E-2
In Commercial Distribution

  • 04547301462558 ()

  • Length: 60 Millimeter
  • Width: 18 Millimeter
NV-ET-M60E-2

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
As packaged, NEOVEIL is a suture- and staple-reinforcement product composed of 100% bioabsorbable polyglycolic acid (PGA). This nonwoven product is dyed with D&C Green No.6 in order to make it readily visible to the surgeon. Two forms of NEOVEIL are provided. The Tube type model constitutes of pre-formed porous bio-absorbable nonwoven sheets and is intended for staple-line reinforcement. The Tube type model is provided in the form of sleeves, one for the cartridge and one for the anvil on a corresponding stapler. After deployment of the tube type reinforcement material, the non-degradable elastic knits, comprised of polyurethane and nylon, are removed and discarded along with the PGA tacking sutures. The Sheet type model is simply a porous fibrous bio-absorbable sheet which is intended for suture-line reinforcement. The thickness of the bioabsorbable NEOVEIL staple line reinforcement ranges from 0.1 mm to 0.85 mm. Mesh weave characteristics and pore size are not applicable since NEOVEIL is nonwoven material. Average basis weight of the NEOVEIL model ranges from 35 to 225 (g/m2).
GUNZE LIMITED
NV-ET-M60A-2
In Commercial Distribution

  • 04547301462534 ()

  • Length: 60 Millimeter
  • Width: 17 Millimeter
NV-ET-M60A-2

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
As packaged, NEOVEIL is a suture- and staple-reinforcement product composed of 100% bioabsorbable polyglycolic acid (PGA). This nonwoven product is dyed with D&C Green No.6 in order to make it readily visible to the surgeon. Two forms of NEOVEIL are provided. The Tube type model constitutes of pre-formed porous bio-absorbable nonwoven sheets and is intended for staple-line reinforcement. The Tube type model is provided in the form of sleeves, one for the cartridge and one for the anvil on a corresponding stapler. After deployment of the tube type reinforcement material, the non-degradable elastic knits, comprised of polyurethane and nylon, are removed and discarded along with the PGA tacking sutures. The Sheet type model is simply a porous fibrous bio-absorbable sheet which is intended for suture-line reinforcement. The thickness of the bioabsorbable NEOVEIL staple line reinforcement ranges from 0.1 mm to 0.85 mm. Mesh weave characteristics and pore size are not applicable since NEOVEIL is nonwoven material. Average basis weight of the NEOVEIL model ranges from 35 to 225 (g/m2).
GUNZE LIMITED
NV-LL-015G
In Commercial Distribution

  • 04548366830337 ()

  • Width: 150 Millimeter
  • Length: 150 Millimeter
NV-LL-015G

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
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