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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 - B382SD225975000

6 Inch Screw Extraction Set, T-Handle
Surgical Direct, Inc.
SD22597-500
In Commercial Distribution

  • B382SD225975000 ()
SD22597-500

  • Surgical screwdriver, reusable

Surgical Direct - B382SD225974010

Distraction Screw 16mm
Surgical Direct, Inc.
SD22597-401
In Commercial Distribution

  • B382SD225974010 ()
SD22597-401

  • Surgical screwdriver, reusable

Surgical Direct - B382SD225974000

Distraction Screw 14mm
Surgical Direct, Inc.
SD22597-400
In Commercial Distribution

  • B382SD225974000 ()
SD22597-400

  • Surgical screwdriver, reusable

Surgical Direct - B382SD225973000

8 Inch Screwdriver for Distraction Screws, Plastic Black Handle
Surgical Direct, Inc.
SD22597-300
In Commercial Distribution

  • B382SD225973000 ()
SD22597-300

  • Surgical screwdriver, reusable

Surgical Direct - B382SD225970000

8 1/4" Screw Extraction Set, Stainless Steel Cover, Plastic Tray
Surgical Direct, Inc.
SD22597-000
In Commercial Distribution

  • B382SD225970000 ()
SD22597-000

  • Surgical screwdriver, reusable

Surgical Direct - B382SD2259750000

Screw Extraction Set
Surgical Direct, Inc.
SD22597-5000
In Commercial Distribution

  • B382SD2259750000 ()
SD22597-5000

  • Surgical screwdriver, reusable

Integra® - 10381780247876

Integra® Total Foot System The TX 8 non-cannulated driver with AO is used in conjunction with the Integra Total Foot system.
Ascension Orthopedics, Inc.
TXDTFS08
In Commercial Distribution

  • M269TXDTFS081 ()
  • 10381780247876 ()

  • 3.5 in L x .13 in dia tip
TXD-TFS-08

  • Surgical screwdriver, reusable

Construct ™ - 10381780247746

Construct® Ankle Fusion Plate System The TX 25 driver shaft with quick connect is used with the Construct Ankle Fusion Plate System.
Ascension Orthopedics, Inc.
TSS-5010-01
In Commercial Distribution

  • M269TSS5010011 ()
  • 10381780247746 ()

  • 4.0 in L x .172 in dia tip
TSS501001

  • Surgical screwdriver, reusable

TruArch® Subtalar Implant System - 10381780247531

Integra® TruArch® The TruArch removal driver is used to remove the implant.
Ascension Orthopedics, Inc.
TA-3115
In Commercial Distribution

  • M269TA31151 ()
  • 10381780247531 ()

  • 165.1 mm L x 5 mm dia
TA-3115

  • Surgical screwdriver, reusable

TruArch® Subtalar Implant System - 10381780247524

Integra® TruArch® The TruArch driver is used for insertion of the implant, as well as adjusting position.
Ascension Orthopedics, Inc.
TA-3110
Not in Commercial Distribution

  • M269TA31101 ()
  • 10381780247524 ()

  • 165.1 mm L x 4 mm dia tip
TA-3110

  • Surgical screwdriver, reusable
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