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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DELIV SYS ENS1022 ENSEMBLE II US
MEDTRONIC, INC.
ENS1022
In Commercial Distribution

  • 00643169713901 ()

  • Outer Balloon Size 22 mm


  • Pulmonary transcatheter heart valve bioprosthesis
DELIV SYS ENS1020 ENSEMBLE II US
MEDTRONIC, INC.
ENS1020
In Commercial Distribution

  • 00643169713895 ()

  • Outer Balloon Size 20 mm


  • Pulmonary transcatheter heart valve bioprosthesis
DELIV SYS ENS1018 ENSEMBLE II US
MEDTRONIC, INC.
ENS1018
In Commercial Distribution

  • 00643169713888 ()

  • Outer Balloon Size 18 mm


  • Pulmonary transcatheter heart valve bioprosthesis
LIT 3330L DYSTONIA 37603
MEDTRONIC, INC.
3330
In Commercial Distribution

  • 00643169091153 ()


  • Deep brain electrical stimulation system
LIT 3320L DYSTONIA 37602 INS
MEDTRONIC, INC.
3320
In Commercial Distribution

  • 00643169091146 ()


  • Deep brain electrical stimulation system
LIT 3310L DYSTONIA 37601 INS
MEDTRONIC, INC.
3310
In Commercial Distribution

  • 00643169091115 ()


  • Deep brain electrical stimulation system
No Description
Fujirebio Diagnostics, Inc.
801-905
Not in Commercial Distribution

  • 00869164000000 ()

  • Size Type = Tests Per Kit; Size Unit = 96; Unit of Measure = Tests


  • Mucin-like carcinoma-associated antigen (MCA) IVD, kit, enzyme immunoassay (EIA)
PulseRider Aneurysm Neck Reconstruction Device Connection Cable
Medos International Sàrl
PRDSACD
Not in Commercial Distribution

  • 00859030005260 ()
PRDSACD

  • Bare-metal intracranial vascular stent
PulseRider Aneurysm Neck Reconstruction Device Detachment System Controller
Medos International Sàrl
PRDSCBD
Not in Commercial Distribution

  • 00859030005253 ()
PRDSCBD

  • Vascular implant detacher, electronic, reusable
PulseRider Aneurysm Neck Reconstruction Device, 2.7 to 3.5 mm, 8 mm, T Shape
Medos International Sàrl
201-D
Not in Commercial Distribution

  • 00859030005154 ()
201-D

  • Bare-metal intracranial vascular stent
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