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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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Introducer set with hemostatic valve, 12F
Oscor Inc.
DYNJINTROL12
Not in Commercial Distribution

  • 20889942000286 ()
  • 10889942000289 ()

  • Guidewire Length: 50 cm, OD: 0.038 in
  • Lumen/Inner Diameter: 4 Millimeter
  • Needle 18 G
  • Dilator Length 28 cm
  • Sheath Length 23 cm
  • Syringe 10 cc
DYNJINTROL12

  • Vascular catheter introduction set, nonimplantable
Introducer set with hemostatic valve, 11F
Oscor Inc.
DYNJINTROL11
Not in Commercial Distribution

  • 20889942000279 ()
  • 10889942000272 ()

  • Syringe 10 cc
  • Lumen/Inner Diameter: 3.7 Millimeter
  • Needle 18 G
  • Guidewire Length: 50 cm, OD: 0.038 in
  • Sheath Length 23 cm
  • Dilator Length 28 cm
DYNJINTROL11

  • Vascular catheter introduction set, nonimplantable
Introducer set with hemostatic valve, 10F
Oscor Inc.
DYNJINTROL10
Not in Commercial Distribution

  • 20889942000217 ()
  • 10889942000210 ()

  • Sheath Length 23 cm
  • Syringe 10 cc
  • Dilator Length 28 cm
  • Guidewire Length: 50 cm, OD: 0.038 in
  • Lumen/Inner Diameter: 3.4 Millimeter
  • Needle 18 G
DYNJINTROL10

  • Vascular catheter introduction set, nonimplantable
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
No Description
Merit Medical Systems, Inc.
Initial Release
In Commercial Distribution

  • 10884450785123 ()
  • 00884450785126 ()

  • Needle Gauge (G)-21G
  • Guide Wire Diameter (OD)-0.018" (0.46 mm)
  • Introducer French Size (F)-5F
  • Introducer Length (cm)-10 cm (4")
ACE521PTE

  • Vascular dilator, single-use
No Description
Merit Medical Systems, Inc.
00884450785119
In Commercial Distribution

  • 10884450785116 ()
  • 00884450785119 ()

  • Introducer French Size (F)-4F
  • Guide Wire Diameter (OD)-0.018" (0.46 mm)
  • Introducer Length (cm)-10 cm (4")
  • Needle Gauge (G)-21G


  • Vascular dilator, single-use
  • Laparoscopic access cannula, single-use
No Description
Merit Medical Systems, Inc.
00884450783368
In Commercial Distribution

  • 10884450783365 ()
  • 00884450783368 ()

  • Introducer French Size (F)-5F
  • Introducer Length (cm)-10 cm (4")
  • Needle Gauge (G)-21G
  • Guide Wire Diameter (OD)-0.018" (0.46 mm)
ACE501PTS

  • Vascular dilator, single-use
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