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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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HawkOne™ - 00643169968554

ATHERECTOMY H1-14550 CUTTER DRIVER UNI
Covidien LP
H1-14550
In Commercial Distribution

  • 00643169968554 ()


  • Mechanical atherectomy system catheter, peripheral

HALO TRAUMA KIT - 00650551003861

TRAUMA KIT, 1211-1S SMALL SHORT RING, 1206-20 HEADBLOCK, 1206-11 TRACTION BAIL, (2) 1201-43 3" SKULL PINS, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6SS1
In Commercial Distribution

  • 00650551003861 ()


  • Cervical spine immobilization system, single-use

SubQ It! Bioabsorbable Skin Closure System - 00867469000220

SubQ It! Bioabsorbable Driver SU-10 is a single-patient use, skin closure device, preloaded with 10 bioabsorbable dermal fasteners, packaged sterile in a protective foil pouch.
OPUS KSD, INC.
SU-10
In Commercial Distribution

  • 10867469000227 ()
  • 00867469000220 ()
412010

  • Skin stapler/staple, bioabsorbable

MatrixPRO Driver Battery Pack, Sterile - 00862377000119

No Description
PRO-DEX, INC.
05.000.021S
In Commercial Distribution

  • 00862377000119 ()
  • 10862377000116 ()
  • 20862377000113 ()


  • Disposable battery pack

PONTiS Flexor Tendon Repair System - 00859210006025

PONTiS 3mm Anchor with Anchor Driver for Flexor Tendon Repair Each Kit contains: 1x 3mm Anchor with Driver handle Anchor has size #3-0 multifilament SS suture Each end of SS suture has pre-attached straight needles. Supplied pouched, sterilized with EO.
PONTIS ORTHOPAEDICS, LLC
400-3031
In Commercial Distribution

  • 00859210006025 ()

  • Length: 4.5 Millimeter
  • Outer Diameter: 3 Millimeter
400-3031

  • Tendon/ligament bone anchor, non-bioabsorbable

ZipE® Knotless Tissue Repair and Attachment Devices - 00858816006026

ZipE® Knotless Tissue Repair and Attachment Devices 5.0 mm titanium screw, 6.5 resorbable capture, #2 braided suture, and driver
ZIPTEK LLC
A6-6550-S
In Commercial Distribution

  • 00858816006026 ()


  • Tendon/ligament bone anchor, non-bioabsorbable

ZipE® Knotless Tissue Repair and Attachment Devices - 00858816006002

ZipE® Knotless Tissue Repair and Attachment Devices - RA6-6550-S 5.0 mm resorbable plug, 6.5 mm resorbable capture, #2 braided suture, and driver
ZIPTEK LLC
RA6-6550-S
In Commercial Distribution

  • 00858816006002 ()


  • Tendon/ligament bone anchor, bioabsorbable

ZipE® Knotless Tissue Repair and Attachment Devices - 00858816006033

ZipE® Knotless Tissue Repair and Attachment Devices - A6-6545-S 4.5 mm titanium screw, 6.5 resorbable capture, #2 braided suture, and driver
ZIPTEK LLC
A6-6545-S
In Commercial Distribution

  • 00858816006033 ()


  • Tendon/ligament bone anchor, non-bioabsorbable

ZipE® Knotless Tissue Repair and Attachment Devices - 00858816006019

ZipE® Knotless Tissue Repair and Attachment Devices - RA6-6565-S 6.5 mm resorbable plug, 6.5 mm resorbable capture, #2 braided suture, and driver
ZIPTEK LLC
RA6-6565-S
In Commercial Distribution

  • 00858816006019 ()


  • Tendon/ligament bone anchor, bioabsorbable

OsteoMed™ Power Driver - 00873263003657

OsteoMed Singe use Sterile Power Driver, 1x, for use with WayPoint Combo Driver bit
FHC, INC.
68-OM-SD-00365
In Commercial Distribution

  • 00873263003657 ()
68-OM-SD

  • Neurological stereotactic surgery system
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