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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Driver, T10 Hexalobe, Beveled FT
ARTHREX, INC.
AR-8741-40
In Commercial Distribution

  • 00888867362635 ()
AR-8741-40

  • Orthopaedic implant driver
PRO-STOP PLUS T15 HEXALOBE DRIVER, 14MM
ARTHREX, INC.
AR-4201DB-14
In Commercial Distribution

  • 00888867102606 ()
AR-4201DB-14

  • Orthopaedic implant driver
iBALANCE TKA, PIN DRIVER
ARTHREX, INC.
AR-613-91
In Commercial Distribution

  • 00888867116900 ()
AR-613-91

  • Orthopaedic implant driver
PRO-STOP PLUS T15 HEXALOBE DRIVER, 16MM
ARTHREX, INC.
AR-4201DB-16
In Commercial Distribution

  • 00888867102613 ()
AR-4201DB-16

  • Orthopaedic implant driver
INnate Sterile Instrument Kit The kit contains two guide wires, one cannulated drill, and one cannulated driver.
Exsomed Corporation
EXINN914500
Not in Commercial Distribution

  • B487EXINN9145000 ()
EXINN914500

  • Orthopaedic implant driver
  • Orthopaedic guidewire, single-use
  • Cannulated surgical drill bit, single-use
  • Surgical depth gauge, single-use
INnate Sterile Instrument Kit The kit contains two guide wires, one cannulated drill, and one cannulated driver.
Exsomed Corporation
EXINN913600
Not in Commercial Distribution

  • B487EXINN9136000 ()
EXINN913600

  • Orthopaedic implant driver
  • Orthopaedic guidewire, single-use
  • Cannulated surgical drill bit, single-use
  • Surgical depth gauge, single-use
NanoPhix sterile instrument kit. The kit contains 1 depth gauge, 2 guide wires, 1 driver.
Exsomed Corporation
EXINN911500
Not in Commercial Distribution

  • B487EXINN9115000 ()
EXINN911500

  • Surgical depth gauge, single-use
  • Orthopaedic guidewire, single-use
  • Orthopaedic implant driver
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)
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