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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



  • 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

  • 13700773735096 ()


  • 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

  • 13760087123835 ()


  • 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
S1.4122
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
uraPly™ Antimicrobial Wound Matrix (fenestrated) consists of a collagen sheet coated with polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly™ Antimicrobial Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches.
ORGANOGENESIS INC.
515-067
Not in Commercial Distribution

  • 00618474000442 ()

  • Width: 3 Centimeter
  • Length: 4 Centimeter


  • Animal-derived wound matrix dressing
PermaLife Cell Culture Bag, 120 mL - no green vent cap
ORIGEN BIOMEDICAL, INC.
PL120-2G
In Commercial Distribution

  • 20816203024354 ()
  • 10816203024357 ()
PL120-2G

  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 120 mL, with SCD tubing
ORIGEN BIOMEDICAL, INC.
PL120N
In Commercial Distribution

  • 20816203024347 ()
  • 10816203024340 ()
PL120N

  • Blood/tissue storage/culture container
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