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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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Surgical Direct - B382SDL510200

Screw Driver Handle for 1.0, 1.5, and 2.0 Screws
Surgical Direct, Inc.
SDL51020
In Commercial Distribution

  • B382SDL510200 ()
SDL51020

  • Surgical screwdriver, reusable

Reprocessed 2.0mm Cannulated Hex Driver - B390HT11201

No Description
SURETEK MEDICAL
HT-1120
In Commercial Distribution

  • B390HT11201 ()


  • Fluted surgical drill bit, single-use

INnate Instrument Kit - B487EXINN9145000

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 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)

Apollo Anterior Cervical Plate System - B521115312010

Apollo Retaining Driver AO Connect Shaft
AURORA SPINE, INC.
115-312-01
In Commercial Distribution

  • B521115312010 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Integra® Jarit® - 10381780509073

Integra® Jarit® Lucae Mallet, 7-3/4", 5 Oz Head Weight, 1" Diameter
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
P4215
In Commercial Distribution

  • M274P42151 ()
  • 10381780509073 ()
P4215

  • Surgical mallet
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