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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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Ziptek large stainless steel driver/handle assembly reusable medical grade stainless steel ofr use with large 5.0mm screws and biocomposite plugs and as ZipE capture/button pusher
ZIPTEK LLC
B56-793-S_D
In Commercial Distribution

  • 00858816006101 ()
01

  • Surgical instrument handle, non-torque-limiting
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 - 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
Pin Driver, Tri-flat, Hudson Connector
Orthalign, Inc.
403162
In Commercial Distribution

  • 00858704006954 ()
403162

  • Orthopaedic surgical procedure kit, non-medicated, reusable
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
OsteoMed Manual Driver Handle
FHC, INC.
66-WP-DH-00323
In Commercial Distribution

  • 00873263003237 ()
66-WP-DH

  • Neurological stereotactic surgery system
WayPoint Combination Driver Bit with Collar
FHC, INC.
66-WP-CD-01-00320
In Commercial Distribution

  • 00873263003206 ()
66-WP-CD-01

  • Neurological stereotactic surgery system
WayPoint Combination Driver Bit
FHC, INC.
66-WP-CD-00318
In Commercial Distribution

  • 00873263003183 ()
66-WP-CD

  • Neurological stereotactic surgery system
WayPoint Surgical Kit Contains: Anchor Hex Wrench - 66-WP-HW Burr Hole Entry Marker Tool & Bushing 66-MP-EM STar SteriSuite Case 6mm Standoff Wrench - 66-WP-SW WayPoint Driver Handle - 66-WP-DH Combination Driver Bit - 66-WP-CD microTargeting Sterilization Tray - 67-00-1
FHC, INC.
66-WP-MR-00317
Not in Commercial Distribution

  • 00873263001721 ()
  • 00873263003176 ()
66-WP-MR

  • Neurological stereotactic surgery system
Salgado Driver, Large, 35 cm Length
SURGIN SURGICAL INSTRUMENTATION, INC.
CR2005
In Commercial Distribution

  • 00868742000135 ()
CR2005

  • Surgical mallet
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