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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CERENOVUS ENTERPRISE 2 Vascular Reconstruction Device Stent OD (mm) 4.0 Stent Length (mm) 16 NO DISTAL TIP Recommended Microcatheter .021 Inch (0.533mm) Maximum Stent Foreshortening 1.2 mm Humanitarian Device USA ONLY): Authorized by Federal Law for use with embolic coils for the treatment of wide-neck, intracranial, saccular, or fusiform aneurysms arising from a parent vessel with a diameter of greater than or equal to 2.5mm and less than or equal to 4mm. Wide-neck is defined as having a neck width greater than or equal to 4mm or a dome-to-neck ratio less than 2mm. The effectiveness of this device for this use has not been demonstrated.
Medos International Sàrl
ENF401600
In Commercial Distribution

  • 10886704075349 ()
ENF401600

  • Bare-metal intracranial vascular stent
S.R. MCP INSTRUMENT SET, PHALANGEAL IMPACTOR
Stryker GmbH
17-1538
In Commercial Distribution

  • 00886385020976 ()


  • Orthopaedic implant driver
S.R. MCP INSTRUMENT SET, METACARPAL IMPACTOR
Stryker GmbH
17-1537
In Commercial Distribution

  • 00886385020969 ()


  • Orthopaedic implant driver
SR PIP INSTRUMENT SET, DISTAL IMPACTOR
Stryker GmbH
17-1354
In Commercial Distribution

  • 00886385020075 ()


  • Orthopaedic implant driver
PIP PROXIMAL IMPACTOR ASSEMBLY
Stryker GmbH
17-1353
In Commercial Distribution

  • 00886385020068 ()


  • Orthopaedic implant driver
Working Insert, with steering lever
Karl Storz GmbH & Co. KG
26161UH
In Commercial Distribution

  • 04048551230497 ()


  • Rigid endoscope working guide
S.R. MCP PHALANGEAL BROACH ASSEMBLY, XL
Stryker GmbH
17-1524
In Commercial Distribution

  • 00886385020945 ()


  • Orthopaedic broach
S.R. MCP PHALANGEAL BROACH ASSEMBLY, LG
Stryker GmbH
17-1523
In Commercial Distribution

  • 00886385020938 ()


  • Orthopaedic broach
S.R. MCP PHALANGEAL BROACH ASSEMBLY, MD
Stryker GmbH
17-1522
In Commercial Distribution

  • 00886385020921 ()


  • Orthopaedic broach
S.R. MCP PHALANGEAL BROACH ASSEMBLY, SM
Stryker GmbH
17-1521
In Commercial Distribution

  • 00886385020914 ()


  • Orthopaedic broach
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