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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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MISAGO RX Self-expanding Peripheral Stent
TERUMO CORPORATION
SXR07100L
In Commercial Distribution

  • 54987350722220 ()
  • 04987350722225 ()

  • Distal Tip and Sheath are coated with Hydrophilic Polymer
  • Catheter Usable Length: 135 centimeters
  • Length: 100 Millimeter
  • Lumen/Inner Diameter: 7 Millimeter
SX*FXA07X0LN

  • Peripheral artery stent, bare-metal
MISAGO RX Self-expanding Peripheral Stent
TERUMO CORPORATION
SXR07080L
In Commercial Distribution

  • 54987350722206 ()
  • 04987350722201 ()

  • Distal Tip and Sheath are coated with Hydrophilic Polymer
  • Catheter Usable Length: 135 centimeters
  • Length: 80 Millimeter
  • Lumen/Inner Diameter: 7 Millimeter
SX*FXA0780LN

  • Peripheral artery stent, bare-metal
MISAGO RX Self-expanding Peripheral Stent
TERUMO CORPORATION
SXR07060L
In Commercial Distribution

  • 54987350722183 ()
  • 04987350722188 ()

  • Distal Tip and Sheath are coated with Hydrophilic Polymer
  • Catheter Usable Length: 135 centimeters
  • Length: 60 Millimeter
  • Lumen/Inner Diameter: 7 Millimeter
SX*FXA0760LN

  • Peripheral artery stent, bare-metal
MISAGO RX Self-expanding Peripheral Stent
TERUMO CORPORATION
SXR07040L
In Commercial Distribution

  • 54987350722169 ()
  • 04987350722164 ()

  • Distal Tip and Sheath are coated with Hydrophilic Polymer
  • Catheter Usable Length: 135 centimeters
  • Length: 40 Millimeter
  • Lumen/Inner Diameter: 7 Millimeter
SX*FXA0740LN

  • Peripheral artery stent, bare-metal
MISAGO RX Self-expanding Peripheral Stent
TERUMO CORPORATION
SXR06150L
In Commercial Distribution

  • 54987350722145 ()
  • 04987350722140 ()

  • Distal Tip and Sheath are coated with Hydrophilic Polymer
  • Catheter Usable Length: 135 centimeters
  • Length: 150 Millimeter
  • Lumen/Inner Diameter: 6 Millimeter
SX*FXA06X5LN

  • Peripheral artery stent, bare-metal
MISAGO RX Self-expanding Peripheral Stent
TERUMO CORPORATION
SXR06120L
In Commercial Distribution

  • 54987350722121 ()
  • 04987350722126 ()

  • Distal Tip and Sheath are coated with Hydrophilic Polymer
  • Catheter Usable Length: 135 centimeters
  • Length: 120 Millimeter
  • Lumen/Inner Diameter: 6 Millimeter
SX*FXA06X2LN

  • Peripheral artery stent, bare-metal
Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure Instrument for teeth of different pulp chamber depths. The Sealing Caps include a color-coded surface to match the proper Sealing Cap to the proper Depth Gauge. Additionally, Sealing Caps feature a sealing element intended to keep air out of the root canal system and procedure fluid inside the tooth.
SONENDO, INC.
FG-001-00009
In Commercial Distribution

  • 00858395006417 ()
  • 00858395006141 ()
GW-MOL-SP09

  • Dental delivery system instrument unit, electric
Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure Instrument for teeth of different pulp chamber depths. The Sealing Caps include a color-coded surface to match the proper Sealing Cap to the proper Depth Gauge. Additionally, Sealing Caps feature a sealing element intended to keep air out of the root canal system and procedure fluid inside the tooth.
SONENDO, INC.
FG-001-00009
In Commercial Distribution

  • 00858395006073 ()
  • 00858395006141 ()
GW-MOL-SP09

  • Dental delivery system instrument unit, electric
No Description
SURGENTEC, LLC
FC-G-16S
In Commercial Distribution

  • 00858406007570 ()


  • Spinal guidewire
ANTI-NUCLEAR ANTIBODY ELISA TEST KIT, 40 TESTS OF 9 INDIVIDUAL ANTIGENS
THERA-TEST LABORATORIES, INC
104-005
In Commercial Distribution

  • 00854473003071 ()
104-005

  • Centromere protein antibody (anti-CENP) IVD, kit, enzyme immunoassay (EIA)
  • Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA)
  • Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA)
  • SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)
  • SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)
  • Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA)
  • Smith antibody (anti-Sm) IVD, kit, enzyme immunoassay (EIA)
  • Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA)
  • Single stranded DNA antibody (anti-ssDNA) IVD, kit, enzyme immunoassay (EIA)
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