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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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CARDINAL HEALTH - 10885425799022

STERILE RETINAL SUPPLY PACK
Cardinal Health 200, LLC
SEY51RSKID
In Commercial Distribution

  • 50885425799020 ()
  • 10885425799022 ()
SEY51RSKID

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

Orbit Subretinal Delivery System - 00860000540568

Third Arm Kit
Gyroscope Usa, Inc.
JANS0030
In Commercial Distribution

  • 00860000540568 ()


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

Orbit Subretinal Delivery System - 00860000540551

Trayed Tube Set
Gyroscope Usa, Inc.
PN1007256
In Commercial Distribution

  • 00860000540551 ()


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

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

Regard™ - 10194717103165

No Description
ROI CPS, LLC
EY00099A
Not in Commercial Distribution

  • 20194717103162 ()
  • 10194717103165 ()


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

Regard™ - 10194717102717

No Description
ROI CPS, LLC
EY00036I
Not in Commercial Distribution

  • 20194717102714 ()
  • 10194717102717 ()


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