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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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Subretinal Access Kit - Straight
Gyroscope Usa, Inc.
PN1007128-002
In Commercial Distribution

  • 00860000540506 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
Subretinal Delivery System Assembly, 100µL
Gyroscope Usa, Inc.
PN1008946-001
In Commercial Distribution

  • 00850009362032 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
Dosing Set, 100µL
Gyroscope Usa, Inc.
PN1008927-001
In Commercial Distribution

  • 00850009362025 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
Tubing Set
Gyroscope Usa, Inc.
PN1008919-001
In Commercial Distribution

  • 00850009362018 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
Subretinal Injection Device Set
Gyroscope Usa, Inc.
PN1008904-001
In Commercial Distribution

  • 00850009362001 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
No Description
Hasa Optix
HA-SET061
In Commercial Distribution

  • 05404027449289 ()
  • 05404027449272 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
No Description
Hasa Optix
HA-SET060
In Commercial Distribution

  • 05404027449265 ()
  • 05404027449258 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
No Description
Hasa Optix
HA-SET056
In Commercial Distribution

  • 15404027449231 ()
  • 05404027449234 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
No Description
Hasa Optix
HA-SET058
In Commercial Distribution

  • 15404027449187 ()
  • 05404027449180 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
No Description
Hasa Optix
HA-SET059
In Commercial Distribution

  • 15404027449170 ()
  • 05404027449173 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
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