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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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1.5mm Drill
CPM Medical Consultants, LLC
Rev A
In Commercial Distribution

  • B565FO20010 ()
FO-2001

  • Orthopaedic bone staple driver
Solid T20 Screwdriver
Wishbone Medical, Inc.
SDRASS20
Not in Commercial Distribution

  • B562SDRASS200 ()


  • Surgical screwdriver, reusable
Solid T15 Screwdriver
Wishbone Medical, Inc.
SDRASS15
Not in Commercial Distribution

  • B562SDRASS150 ()


  • Surgical screwdriver, reusable
Piston Driver
INTEGRA LIFESCIENCES CORPORATION
428A1060
In Commercial Distribution

  • M268428A10601 ()
  • 10381780254805 ()


  • Skull clamp
Integra® External Fixation System The Maintenance Kit consists of a 10mm and 13mm box wrench, a universal bolt tubular wrench, a pivoting socket wrench, and a k-wire guide. These instruments are used with the Integra External Fixation System.
Ascension Orthopedics, Inc.
1222MAINKIT
Not in Commercial Distribution

  • M2691222MAINTKIT1 ()
  • 10381780248231 ()

  • N/A
1222MAINKIT

  • External orthopaedic fixation system, reusable
Integra® External Fixation System The wire tensioner is used to apply tension to the wires after they are run through the bone and attached to the ring.
Ascension Orthopedics, Inc.
12225300
In Commercial Distribution

  • M269122253001 ()
  • 10381780248149 ()

  • .004 in opening
12225300

  • External orthopaedic fixation system, reusable
Integra® External Fixation System The provisional midfoot support is used with the external fixation system.
Ascension Orthopedics, Inc.
12225060
In Commercial Distribution

  • M269122250601 ()
  • 10381780248132 ()

  • 5.702 in L
12225060

  • External orthopaedic fixation system, reusable
Integra® External Fixation System The provisional heel support is used with the external fixation system.
Ascension Orthopedics, Inc.
12225050
In Commercial Distribution

  • M269122250501 ()
  • 10381780248125 ()

  • 6.238 in L
12225050

  • External orthopaedic fixation system, reusable
Integra® External Fixation System The provisional calf support is used with the external fixation system.
Ascension Orthopedics, Inc.
12225040
In Commercial Distribution

  • M269122250401 ()
  • 10381780248118 ()

  • 6.883 in L
12225040

  • External orthopaedic fixation system, reusable
Integra® External Fixation System The wire cutter is a tool used to cut wire with the External Fixation System.
Ascension Orthopedics, Inc.
12224508
In Commercial Distribution

  • M269122245081 ()
  • 10381780248101 ()

  • 222.7 mm L
12224508

  • External orthopaedic fixation system, reusable
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