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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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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.
BIOSTONE CO. LIMITED
OBS1205
In Commercial Distribution

  • 05060548020002 ()
OBS1205

  • Bone matrix implant, synthetic, non-antimicrobial
It is used to deliver the laser beam from the main laser device into the eye. The sterilized endophoto probe comes already sterilized at the factory and is disposable. Sterilized endophoto probes are available in a variety of tip shapes and diameters.
NIDEK CO.,LTD.
11143-7500
In Commercial Distribution

  • 04987669100417 ()
  • 04987669101322 ()

  • Needle Gauge: 25 Gauge


  • Ophthalmic laser system beam guide
It is used to deliver the laser beam from the main laser device into the eye. The sterilized endophoto probe comes already sterilized at the factory and is disposable. Sterilized endophoto probes are available in a variety of tip shapes and diameters.
NIDEK CO.,LTD.
11143-7300
In Commercial Distribution

  • 04987669100400 ()
  • 04987669101315 ()

  • Needle Gauge: 23 Gauge


  • Ophthalmic laser system beam guide
It is used to deliver the laser beam from the main laser device into the eye. The sterilized endophoto probe comes already sterilized at the factory and is disposable. Sterilized endophoto probes are available in a variety of tip shapes and diameters.
NIDEK CO.,LTD.
11143-7000
In Commercial Distribution

  • 04987669100394 ()
  • 04987669101308 ()

  • Needle Gauge: 20 Gauge


  • Ophthalmic laser system beam guide
It is used to deliver the laser beam from the main laser device into the eye. The sterilized endophoto probe comes already sterilized at the factory and is disposable. Sterilized endophoto probes are available in a variety of tip shapes and diameters.
NIDEK CO.,LTD.
11143-6700
In Commercial Distribution

  • 04987669100387 ()
  • 04987669101292 ()

  • Needle Gauge: 27 Gauge


  • Ophthalmic laser system beam guide
It is used to deliver the laser beam from the main laser device into the eye. The sterilized endophoto probe comes already sterilized at the factory and is disposable. Sterilized endophoto probes are available in a variety of tip shapes and diameters.
NIDEK CO.,LTD.
11143-6600
In Commercial Distribution

  • 04987669100370 ()
  • 04987669101285 ()

  • Needle Gauge: 25 Gauge


  • Ophthalmic laser system beam guide
It is used to deliver the laser beam from the main laser device into the eye. The sterilized endophoto probe comes already sterilized at the factory and is disposable. Sterilized endophoto probes are available in a variety of tip shapes and diameters.
NIDEK CO.,LTD.
11143-6500
In Commercial Distribution

  • 04987669100363 ()
  • 04987669101278 ()

  • Needle Gauge: 25 Gauge


  • Ophthalmic laser system beam guide
The device is used to inject fluids into, or withdraw fluids from, the body.
JMS CO., LTD.
551721050
In Commercial Distribution

  • 04987494066261 ()
  • 34987494066262 ()

  • Total Volume: 100 Milliliter


  • General-purpose syringe, single-use
Nerbridge® is a product composed of polyglycolic acid and collagen derived from porcine skin. Nerbridge® is a flexible, resorbable and semipermeable tubular membrane matrix filled with porous collagen that provides a non-constricting encasement for injured peripheral nerves for protection of the neural environment. Nerbridge® is designed to be an interface between the nerve and the surrounding tissue. When hydrated, Nerbridge® is an easy to handle, pliable, soft, non-friable, porous conduit. The resilience of Nerbridge® allows the product to recover and maintain closure without constricting the nerve once the device is placed around the nerve. Nerbridge® is manufactured using validated viral inactivation and removal processes for the collagen. The product is provided in a foil pouch, sterile, non-pyrogenic, for single use only, in a variety of sizes, and placed in an outer Tyvek header bag for added protection.
TOYOBO CO., LTD.
RN04025E
Not in Commercial Distribution

  • 04965838907463 ()

  • Inner Diameter: 4.0mm and Length: 25mm
RN04025E

  • Nerve guide, animal-derived
Nerbridge® is a product composed of polyglycolic acid and collagen derived from porcine skin. Nerbridge® is a flexible, resorbable and semipermeable tubular membrane matrix filled with porous collagen that provides a non-constricting encasement for injured peripheral nerves for protection of the neural environment. Nerbridge® is designed to be an interface between the nerve and the surrounding tissue. When hydrated, Nerbridge® is an easy to handle, pliable, soft, non-friable, porous conduit. The resilience of Nerbridge® allows the product to recover and maintain closure without constricting the nerve once the device is placed around the nerve. Nerbridge® is manufactured using validated viral inactivation and removal processes for the collagen. The product is provided in a foil pouch, sterile, non-pyrogenic, for single use only, in a variety of sizes, and placed in an outer Tyvek header bag for added protection.
TOYOBO CO., LTD.
RN03525E
Not in Commercial Distribution

  • 04965838907456 ()

  • Inner diameter: 3.5mm and Length: 25mm
RN03525E

  • Nerve guide, animal-derived
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