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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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Reprocessed Visions PV.035 Digital IVUS Catheter
Vein360 LLC
VEN-PV-035
In Commercial Distribution

  • 00860036000531 ()
VEN-PV-035

  • Intravascular ultrasound imaging catheter, reprocessed
Vein360 Reprocessed Visions PV.014P RX Digital IVUS Catheter (014R)
Vein360 LLC
VEN-PV-014R
In Commercial Distribution

  • 00860036000517 ()
VEN-PV-014R

  • Intravascular ultrasound imaging catheter, reprocessed
No Description
Anuncia Medical, Inc.
A022-1
In Commercial Distribution

  • 00860024001847 ()
A022-1

  • Ventriculo-peritoneal/atrial shunt
No Description
Dib UltraNav Medical LLC
DIB-035
In Commercial Distribution

  • 00860013955960 ()


  • Cardiac transseptal access set
No Description
Dib UltraNav Medical LLC
DIB-025
In Commercial Distribution

  • 00860013955946 ()


  • Cardiac transseptal access set
Small Hand Wrap (Box of 10)
MCCONNELL ORTHOPEDIC MFG. CO.
12-220
In Commercial Distribution

  • 00860013953584 ()
12-220

  • Upper-limb traction wrap/trap, single-use
Small Arm Support Wrap with Traction Strap (Box of 10)
MCCONNELL ORTHOPEDIC MFG. CO.
12-411
In Commercial Distribution

  • 00860013953577 ()
12-411

  • Upper-limb traction wrap/trap, single-use
Large Arm Support Wrap with Traction Strap (Box of 10)
MCCONNELL ORTHOPEDIC MFG. CO.
12-401
In Commercial Distribution

  • 00860013953553 ()
12-401

  • Upper-limb traction wrap/trap, single-use
Tendon Seamâ„¢ Magazine - 4 Anchor
Integrity Orthopaedics, Inc
901004
In Commercial Distribution

  • 00860013905989 ()
901004

  • Tendon/ligament bone anchor, non-bioabsorbable
Delivery Instrument, included with Tendon Seamâ„¢ Instrument Kit - 4 Anchor
Integrity Orthopaedics, Inc
902001
In Commercial Distribution

  • 00860013905965 ()
902001

  • Orthopaedic inorganic implant inserter/extractor, single-use
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