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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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Radixact®, Treatment Delivery Console (TDC) - M65810565930

Software, Version 1.0.0.3, Treatment Delivery Console (TDC), Radixact (Operating Software for Radixact® Treatment Delivery System)
ACCURAY INCORPORATED
1056593
In Commercial Distribution

  • M65810565930 ()
NA

  • Linear accelerator system

Radixact®, Treatment Delivery Console - M65810554870

Software, Version 1.0.0.2, Treatment Delivery Console, Radixact Version 1.0.0.2 (Operating Software for Radixact Treatment Delivery System)
ACCURAY INCORPORATED
1055487
In Commercial Distribution

  • M65810554870 ()
NA

  • Linear accelerator system

Radixact®, Treatment Delivery Console (TDC) - M65810502410

Software, Version 1.0.0.1, Treatment Delivery Console (TDC), Radixact (Operating Software for Radixact® Treatment Delivery System)
ACCURAY INCORPORATED
1050241
In Commercial Distribution

  • M65810502410 ()
NA

  • Linear accelerator system

QFlow 500 Male-Female Luer Coupler - B238H000036850

Male-Female Luer Coupler
HEMEDEX, INC
NA
In Commercial Distribution

  • B238H000036850 ()
H0000-3685

  • Intracerebral catheter cranial-fixation kit

QFlow 500 Quad Lumen Cranial Bolt Large-Lumen Introducer - B238H000036840

Probe Dura Piercer and Introducer Kit
HEMEDEX, INC
NA
In Commercial Distribution

  • B238H000036840 ()
H0000-3684

  • Intracerebral catheter cranial-fixation kit

QFlow 500 Probe Dura Piercer and Introducer Kit - B238H000036830

Perfusion Probe Dura Piercer and Introducer Kit
HEMEDEX, INC
NA
In Commercial Distribution

  • B238H000036830 ()
H0000-3683

  • Intracerebral catheter cranial-fixation kit

QFlow 500 Bolt Accessory Kit - B238H000036810

Bolt Accessory Kit
HEMEDEX, INC
NA
In Commercial Distribution

  • B238H000036810 ()
H0000-3681

  • Intracerebral catheter cranial-fixation kit

QFlow 500 Titanium Bolt-Quad Lumen Bolt Kit - B238H000036440

Intracranial Quad Lumen Bolt Kit
HEMEDEX, INC
NA
In Commercial Distribution

  • B238H000036440 ()
H0000-3644

  • Intracerebral catheter cranial-fixation kit

QFlow 500 Titanium Bolt-Dual Lumen Bolt Kit with Introducer - B238H000036420

Intracranial Dual lumen bolt kit with introducer
HEMEDEX, INC
NA
In Commercial Distribution

  • B238H000036420 ()
H0000-3642

  • Intracerebral catheter cranial-fixation kit

QFlow 500 Titanium Bolt-Dual Lumen Bolt Kit - B238H000036320

Intracranial Dual Lumen Bolt Kit
HEMEDEX, INC
NA
In Commercial Distribution

  • B238H000036320 ()
H0000-3632

  • Intracerebral catheter cranial-fixation kit
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