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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InFrame sterile instrument kit. The kit contains two step guide wires, one cannulated drill, one depth gauge
Exsomed Corporation
EXINF912000
Not in Commercial Distribution

  • B487EXINF9120000 ()
EXINF912000

  • Surgical depth gauge, single-use
  • Orthopaedic guidewire, single-use
  • Orthopaedic implant driver
ArrowPhix Compression Screw System The System includes the implant, two guide wires, and one driver.
Exsomed Corporation
EXARR902526
Not in Commercial Distribution

  • B487EXARR9025260 ()

  • Length: 26 Millimeter
  • Outer Diameter: 2.5 Millimeter
EXARR902526

  • Orthopaedic implant driver
  • Orthopaedic guidewire, single-use
  • Orthopaedic bone screw, non-bioabsorbable, sterile
ArcPhix Compression Screw System The system includes the implant, two guide wires, one cannulated drill, and a driver.
Exsomed Corporation
EXARC903028
Not in Commercial Distribution

  • B487EXARC9030280 ()

  • Length: 28 Millimeter
  • Outer Diameter: 3.0 Millimeter
EXARC903028

  • Orthopaedic implant driver
  • Orthopaedic guidewire, single-use
  • Cannulated surgical drill bit, single-use
  • Orthopaedic bone screw (non-sliding)
Lag Screw Countersink, 2.0/2.5
IN2BONES USA, LLC
P06 N0691
In Commercial Distribution

  • 00817906029994 ()
P06 N0691

  • Orthopaedic implant driver
Lag Screw Drill, Cannulated 1.6
IN2BONES USA, LLC
P06 N0681
In Commercial Distribution

  • 00817906029987 ()
P06 N0681

  • Orthopaedic implant driver
Lag Screw Driver, T7 Cannulated
IN2BONES USA, LLC
P06 N0671
In Commercial Distribution

  • 00817906029970 ()
P06 N0671

  • Orthopaedic implant driver
LAG SCREW COUNTERSINK, HUDSON, Ø5.0
IN2BONES USA, LLC
P06 N0571
In Commercial Distribution

  • 00817906029963 ()
P06 N0571

  • Orthopaedic implant driver
LAG SCREW DRILL, CANNULATED, HUDSON, Ø4.8
IN2BONES USA, LLC
P06 N0562
In Commercial Distribution

  • 00817906029956 ()
P06 N0562

  • Orthopaedic implant driver
LAG SCREW DRILL, CANNULATED, HUDSON, Ø3.3
IN2BONES USA, LLC
P06 N0561
In Commercial Distribution

  • 00817906029949 ()
P06 N0561

  • Orthopaedic implant driver
LAG SCREW COUNTERSINK, Ø6.7
IN2BONES USA, LLC
P06 N0521
In Commercial Distribution

  • 00817906029925 ()
P06 N0521

  • Orthopaedic implant driver
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