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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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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)
4mm Hex Driver Long
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-DND-0076
In Commercial Distribution

  • B432360CAS00760 ()


  • Robotic surgical navigation system application software
CAS Flex Driver
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-DND-0068
In Commercial Distribution

  • B432360CAS00680 ()


  • Robotic surgical navigation system application software
No Description
Modern Surgical Instruments LLC
81-0106
In Commercial Distribution

  • B4198101060 ()


  • Surgical screwdriver, reusable
No Description
Modern Surgical Instruments LLC
27.10.70
In Commercial Distribution

  • B4192710700 ()


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

  • B471240000020 ()


  • Orthopaedic bone staple driver
Staple Tamp, Small
GRAMERCY EXTREMITY ORTHOPEDICS LLC
24000001
In Commercial Distribution

  • B471240000010 ()


  • Orthopaedic bone staple driver
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