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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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Unibody™ Bone Fiducials (13mm) - 10873263008574

Unibody™ Bone Fiducials (13mm) for use with the Nexframe® Sterotactic System
FHC, INC.
FM-4013-00857
In Commercial Distribution

  • 00873263008577 ()
  • 10873263008574 ()
FM-4013

  • Neurological stereotactic surgery system

Unibody™ Bone Fiducials (10mm) - 10873263008567

Unibody™ Bone Fiducials (10mm) for use with the Nexframe® Sterotactic System
FHC, INC.
FM-4010-00856
In Commercial Distribution

  • 00873263008560 ()
  • 10873263008567 ()
FM-4010

  • Neurological stereotactic surgery system

Unibody™ Bone Fiducials (7mm) - 10873263008550

Unibody™ Bone Fiducials (7mm) for use with the Nexframe® Sterotactic System
FHC, INC.
FM-4007-00855
In Commercial Distribution

  • 00873263008553 ()
  • 10873263008550 ()
FM-4007

  • Neurological stereotactic surgery system

Nexframe Screws - 10873263008048

1.6 x 10mm Cranial Bone Screws (3)
FHC, INC.
SR-10-00804
In Commercial Distribution

  • 00873263008041 ()
  • 10873263008048 ()
SR-10

  • Neurological stereotactic surgery system

Isto Disposable Awl 8.5/9.0 Anchor - B90839940859310

Disposable Awl 8.5/9.0 Anchor
Mainstream Medical Devices, LLC
399-40-859-310
In Commercial Distribution

  • B90839940859310 ()
IFLX-DA-8590

  • Bone awl, single-use

Isto Disposable Awl 7.5/8.0 Anchor - B90839940758311

Disposable Awl 7.5/8.0 Anchor
Mainstream Medical Devices, LLC
399-40-758-311
In Commercial Distribution

  • B90839940758311 ()
IFLX-DA-7580

  • Bone awl, single-use

Isto Disposable Awl 6.5/7.0 Anchor - B90839940657312

Disposable Awl 6.5/7.0 Anchor
Mainstream Medical Devices, LLC
399-40-657-312
In Commercial Distribution

  • B90839940657312 ()
IFLX-DA-6570

  • Bone awl, single-use

Isto Disposable Awl 5.5/6.0 Anchor - B90839940556313

Disposable Awl 5.5/6.0 Anchor
Mainstream Medical Devices, LLC
399-40-556-313
In Commercial Distribution

  • B90839940556313 ()
IFLX-DA-5560

  • Bone awl, single-use

Main-AXS Needle-Spinal Simplicity - B908350009000

Single-Use, Bone Access Needle, Sterile Trocar Stylus & Blunt Cannula
Mainstream Medical Devices, LLC
299-08-900
In Commercial Distribution

  • B908350009000 ()

  • Needle Gauge: 8 Gauge
  • Length: 7 Inch
35-0009-000

  • Bone access channel kit

Main-AXS Needle-Spinal Simplicity - B908350008000

Single Use, Bone Access Needle, Sterile Blunt Stylus & Blunt Cannula with Extra Trocar Stylus
Mainstream Medical Devices, LLC
292-11-920
In Commercial Distribution

  • B908350008000 ()

  • Needle Gauge: 11 Gauge
  • Length: 6 Inch
35-0008-000

  • Bone access channel kit
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