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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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Long Screwdriver Shaft (3.5mm Hex)
X-BOLT ORTHOPEDICS INC.
XNI-021
In Commercial Distribution

  • 05397283000199 ()


  • Surgical screwdriver, reusable
T20 Torx screwdriver (4.5Nm Torque Limit)
X-BOLT ORTHOPEDICS INC.
XNI-020
In Commercial Distribution

  • 05397283000182 ()


  • Surgical screwdriver, reusable
Drive 5.0
Artelon
TA500
In Commercial Distribution

  • 00850003396347 ()
TA500

  • Tendon/ligament bone anchor, non-bioabsorbable
  • Surgical screwdriver, single-use
Drive 3.85
Artelon
TA385
In Commercial Distribution

  • 00850003396330 ()
TA385

  • Tendon/ligament bone anchor, non-bioabsorbable
  • Surgical screwdriver, single-use
TWIST.30
Artelon
TW030
In Commercial Distribution

  • 00850003396323 ()
TW030

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
  • Tendon/ligament bone anchor, non-bioabsorbable
  • Surgical screwdriver, single-use
Solid Pilot Tip Drill Bit Kit
Artelon
61012
In Commercial Distribution

  • 00850003396316 ()

  • Outer Diameter: 4.5 Millimeter
61012

  • Cannulated surgical drill bit, single-use
Cannulated Drill Bit
Artelon
61015
In Commercial Distribution

  • 00850003396279 ()

  • Outer Diameter: 4.5 Millimeter
61015

  • Cannulated surgical drill bit, single-use
TWIST.12
Artelon
TW012
In Commercial Distribution

  • 00850003396248 ()
TW012

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
  • Tendon/ligament bone anchor, non-bioabsorbable
  • Surgical screwdriver, single-use
Solid Pilot Tip Drill Bit Kit
Artelon
61018
In Commercial Distribution

  • 00850003396200 ()

  • Outer Diameter: 4.5 Millimeter
61018

  • Cannulated surgical drill bit, single-use
Socket Driver
K2M, INC.
5401-90005
In Commercial Distribution

  • 10888857152939 ()
5401-90005

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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