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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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A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.
FCI S A S FCI 20 22
S1.4122
In Commercial Distribution

  • 13760087123828 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.
FCI S A S FCI 20 22
S1.4121
In Commercial Distribution

  • 13760087123811 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.
FCI S A S FCI 20 22
S1.4132
In Commercial Distribution



  • Ophthalmic surgical procedure kit, non-medicated, single-use
A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.
FCI S A S FCI 20 22
S1.4131
In Commercial Distribution



  • Ophthalmic surgical procedure kit, non-medicated, single-use
A rigid, non-powered device designed to lead a needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for many different procedures such as guides for urethral injections, guides for transrectal prostate biopsy, image-guided (e.g., ultrasound, MRI) for percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. Disposable imaging-supportive devices (e.g., ultrasound transducer cover/gel) may be included with the device. This is a single-use device.
FCI S A S FCI 20 22
S5.200.P
In Commercial Distribution

  • 23700773723915 ()
  • 13700773723918 ()


  • Needle guide, single-use
A rigid, non-powered device designed to lead a needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for many different procedures such as guides for urethral injections, guides for transrectal prostate biopsy, image-guided (e.g., ultrasound, MRI) for percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. Disposable imaging-supportive devices (e.g., ultrasound transducer cover/gel) may be included with the device. This is a single-use device.
FCI S A S FCI 20 22
S5.200.I
In Commercial Distribution

  • 23700773723908 ()
  • 13700773723901 ()


  • Needle guide, single-use
FCI directional LASER PROBE / EXTENDABLE 25G DORC
FCI S A S FCI 20 22
S9.1325.25
In Commercial Distribution

  • 23700773723526 ()
  • 13700773723529 ()


  • Ophthalmic laser system beam guide
FCI directional LASER PROBE / EXTENDABLE 25G NIDEK
FCI S A S FCI 20 22
S9.1324.25
In Commercial Distribution

  • 23700773723502 ()
  • 13700773723505 ()


  • Ophthalmic laser system beam guide
FCI directional LASER PROBE / EXTENDABLE 25G QUANTEL
FCI S A S FCI 20 22
S9.1323.25
In Commercial Distribution

  • 23700773723489 ()
  • 13700773723482 ()


  • Ophthalmic laser system beam guide
FCI directional LASER PROBE / EXTENDABLE 25G ALCO/COH/ZEISS/ELLEX/OS4
FCI S A S FCI 20 22
S9.1322.25
In Commercial Distribution

  • 13700773723468 ()


  • Ophthalmic laser system beam guide
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