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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Supplemental Software provided on a thumb drive. Enables programming of the electrical stimulation parameters of the implant.
Second Sight Medical Products, Inc.
014300-000
Not in Commercial Distribution

  • 00856264005776 ()
014300

  • Retinal prosthesis system tester/clinical evaluator
Laptop computer that is configured with dedicated, PC-based software that, when connected to the Video Processing Unit, enables programming of the electrical stimulation parameters of the implant.
Second Sight Medical Products, Inc.
014003-006-R
Not in Commercial Distribution

  • 00856264005721 ()
014003

  • Retinal prosthesis system tester/clinical evaluator
Laptop computer that is configured with dedicated, PC-based software that, when connected to the Video Processing Unit, enables programming of the electrical stimulation parameters of the implant.
Second Sight Medical Products, Inc.
014003-004-R
Not in Commercial Distribution

  • 00856264005394 ()
014003

  • Retinal prosthesis system tester/clinical evaluator
External USB Drive for archiving of files from the Clinician Programming System laptop.
Second Sight Medical Products, Inc.
014931-001
Not in Commercial Distribution

  • 00856264005455 ()
014931

  • Retinal prosthesis system tester/clinical evaluator
Cable that connects the Communication Adapter to the Video Processing Unit during programming of Retinal Prosthesis.
Second Sight Medical Products, Inc.
014913-001
Not in Commercial Distribution

  • 00856264005424 ()
014913

  • Retinal prosthesis system tester/clinical evaluator
Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures a minimum of 50 cm2 in area. Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
VERICEL CORPORATION
N/A
In Commercial Distribution

  • W41020AU201S1969 ()

  • Area/Surface Area: 50 Square centimeter


  • Cultured skin autograft/xenograft
Cable that connects the Clinician Programming System to the Communication Adapter during programming of the Retinal Prosthesis.
Second Sight Medical Products, Inc.
014916-002
Not in Commercial Distribution

  • 00856264005448 ()
014916

  • Retinal prosthesis system tester/clinical evaluator
Cable that connects the Clinician Programming System to the Psychophysical Test System during programming of the Retinal Prosthesis.
Second Sight Medical Products, Inc.
014915-001
Not in Commercial Distribution

  • 00856264005431 ()
014915

  • Retinal prosthesis system tester/clinical evaluator
No Description
FUJIREBIO INC.
233436
In Commercial Distribution

  • 04987270233436 ()

  • Size Type = Units per kit; Units = 3; Unit of Measure = 4.5mLs


  • Soluble mesothelin-related peptide (SMRP) IVD, calibrator
The Lixelle(r) beta 2-microglobulin apheresis column is indicated for the treatment of patients with clinically-diagnosed dialysis-related amyloidosis (DRA).
KANEKA CORPORATION
S-35
Not in Commercial Distribution

  • 24993478020239 ()
  • 14993478020232 ()
  • 04993478010045 ()
N/A

  • Haemoperfusion system absorption column
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