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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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Malibu™ - 10889981213732

Cannulated DLTA AO Driver, Extra Short
Seaspine Orthopedics Corporation
91-7255
In Commercial Distribution

  • 10889981213732 ()
91-7255

  • Orthopaedic implant driver

Facet - 10889981213152

Drill, 5.0mm
Seaspine Orthopedics Corporation
FF2-000002
In Commercial Distribution

  • 10889981213152 ()
FF2-000002

  • Orthopaedic implant driver

Mariner MIS - 10889981212551

Final Driver
Seaspine Orthopedics Corporation
MM2-100360
In Commercial Distribution

  • 10889981212551 ()
MM2-100360

  • Surgical screwdriver, reusable

Mariner MIS - 10889981212513

Reducer Multi-Driver
Seaspine Orthopedics Corporation
MM2-100342
In Commercial Distribution

  • 10889981212513 ()
MM2-100342

  • Surgical screwdriver, reusable

Mariner MIS - 10889981212445

MIS Navigation Driver
Seaspine Orthopedics Corporation
MM2-100190
In Commercial Distribution

  • 10889981212445 ()
MM2-100190

  • Surgical screwdriver, reusable

Mariner MIS - 10889981212438

Screw Inserter
Seaspine Orthopedics Corporation
MM2-100180
In Commercial Distribution

  • 10889981212438 ()
MM2-100180

  • Surgical screwdriver, reusable

Disposable Screwdriver Blade - 06903195298587

No Description
Kontour(Xi'An) Medical Technology Co.,Ltd.
BPLD60×φ2.8
In Commercial Distribution

  • 06903195298587 ()
HKTGJ0107010002

  • Surgical screwdriver, single-use

Disposable Screwdriver Blade - 06903195298570

No Description
Kontour(Xi'An) Medical Technology Co.,Ltd.
BPLD50×φ2.8
In Commercial Distribution

  • 06903195298570 ()
HKTGJ0107010001

  • Surgical screwdriver, single-use

High torque ISO Hex Adapter - 05712821012913

A driver for a dental torque wrench for placement and adjustment of dental implants, abutments, abutment screw and prosthetic screws during oral surgery and prosthetic procedures.
Elos Medtech Pinol A/S
ISOHEXADPT
In Commercial Distribution

  • 05712821012906 ()
  • 05712821012913 ()
ISOHEXADPT

  • Surgical torque wrench adaptor

Elos Accurate® Scan Body 22 - 05712821011473

The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
SB-NBA60/BRIDGE-1
In Commercial Distribution

  • 05712821011442 ()
  • 05712821011473 ()
SB-NBA60/BRIDGE-1

  • Dental implant suprastructure, temporary, preformed, reusable
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