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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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INnate Instrument Kit - B487EXINN9136000

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 Instrument Kit - B487EXINN9115000

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 Instrument Kit - B487EXINF9120000

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 System - B487EXARR9025260

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 System - B487EXARC9030280

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)

ATTUNE - 10603295384397

ATTUNE PINNING THREADED WITH PIN DRIVER
DEPUY (IRELAND)
2544-00-121
In Commercial Distribution

  • 10603295384397 ()
254400121

  • Total knee prosthesis implantation guide-instrument kit

GEO Staple System - B471240000020

Staple Tamp, Large
GRAMERCY EXTREMITY ORTHOPEDICS LLC
24000002
In Commercial Distribution

  • B471240000020 ()


  • Orthopaedic bone staple driver

GEO Staple System - B471240000010

Staple Tamp, Small
GRAMERCY EXTREMITY ORTHOPEDICS LLC
24000001
In Commercial Distribution

  • B471240000010 ()


  • Orthopaedic bone staple driver

GEO Bone Screw System - B471212502300

Drill Bit 5.0mmx230mm ZH Cannulated
GRAMERCY EXTREMITY ORTHOPEDICS LLC
21250230
In Commercial Distribution

  • B471212502300 ()

  • Outer Diameter: 5.0 Millimeter
  • Length: 230 Millimeter


  • Cannulated surgical drill bit, single-use

GEO Bone Screw System - B471212501600

Drill Bit 5.0mmx160mm ZH Cannulated
GRAMERCY EXTREMITY ORTHOPEDICS LLC
21250160
In Commercial Distribution

  • B471212501600 ()

  • Length: 160 Millimeter
  • Outer Diameter: 5.0 Millimeter


  • Cannulated surgical drill bit, single-use
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