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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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Orbit Subretinal Delivery System - 00860000540544

Pouched Syringe Kit
Gyroscope Usa, Inc.
PN1007130
In Commercial Distribution

  • 00860000540544 ()


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

Orbit Subretinal Delivery System - 00860000540537

Subretinal Injection Cannula Set - Curved
Gyroscope Usa, Inc.
PN1007138C
In Commercial Distribution

  • 00860000540537 ()


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

Orbit Subretinal Delivery System - 00860000540520

Subretinal Injection Cannula Set - Straight
Gyroscope Usa, Inc.
PN1007138
In Commercial Distribution

  • 00860000540520 ()


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

Orbit Subretinal Delivery System - 00860000540513

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

  • 00860000540513 ()


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

Orbit Subretinal Delivery System - 00860000540506

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

  • 00860000540506 ()


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

Orbit Subretinal Delivery System - 00850009362032

Subretinal Delivery System Assembly, 100µL
Gyroscope Usa, Inc.
PN1008946-001
In Commercial Distribution

  • 00850009362032 ()


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

Orbit Subretinal Delivery System - 00850009362025

Dosing Set, 100µL
Gyroscope Usa, Inc.
PN1008927-001
In Commercial Distribution

  • 00850009362025 ()


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

Orbit Subretinal Delivery System - 00850009362018

Tubing Set
Gyroscope Usa, Inc.
PN1008919-001
In Commercial Distribution

  • 00850009362018 ()


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

Orbit Subretinal Delivery System - 00850009362001

Subretinal Injection Device Set
Gyroscope Usa, Inc.
PN1008904-001
In Commercial Distribution

  • 00850009362001 ()


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

Set Cataracte Ste Genevieve - 05404027449272

No Description
Hasa Optix
HA-SET061
In Commercial Distribution

  • 05404027449289 ()
  • 05404027449272 ()


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