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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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FRENCH ROD BENDER
GAUTHIER BIOMEDICAL, INC.
5161-00-5029 (G160249)
In Commercial Distribution

  • 00858325005657 ()
5161005029

  • Manual orthopaedic bender, reusable
CORONAL BENDER 5.5, RIGHT
GAUTHIER BIOMEDICAL, INC.
5161-00-5028 (GC155010-10)
In Commercial Distribution

  • 00858325005640 ()
5161005028

  • Manual orthopaedic bender, reusable
CORONAL BENDER 5.5, LEFT
GAUTHIER BIOMEDICAL, INC.
5161-00-5027 (GC155010-20)
In Commercial Distribution

  • 00858325005633 ()
5161005027

  • Manual orthopaedic bender, reusable
SAGITTAL BENDER 5.5, RIGHT
GAUTHIER BIOMEDICAL, INC.
5161-00-5026 (GC150088-10)
In Commercial Distribution

  • 00858325005626 ()
5161005026

  • Manual orthopaedic bender, reusable
SAGITTAL BENDER 5.5, LEFT
GAUTHIER BIOMEDICAL, INC.
5161-00-5025 (GC150088-20)
In Commercial Distribution

  • 00858325005619 ()
5161005025

  • Manual orthopaedic bender, reusable
CORONAL BENDER 6.0, RIGHT
GAUTHIER BIOMEDICAL, INC.
5161-00-5024 (GC155006-10)
In Commercial Distribution

  • 00858325005602 ()
5161005024

  • Manual orthopaedic bender, reusable
CORONAL BENDER 6.0, LEFT
GAUTHIER BIOMEDICAL, INC.
5161-00-5023 (GC155006-20)
In Commercial Distribution

  • 00858325005596 ()
5161005023

  • Manual orthopaedic bender, reusable
SAGITTAL BENDER 6.0, RIGHT
GAUTHIER BIOMEDICAL, INC.
5161-00-5022 (GC150085-10)
In Commercial Distribution

  • 00858325005589 ()
5161005022

  • Manual orthopaedic bender, reusable
SAGITTAL BENDER 6,0, LEFT
GAUTHIER BIOMEDICAL, INC.
5161-00-5021 (GC150085-20)
In Commercial Distribution

  • 00858325005572 ()
5161005021

  • Manual orthopaedic bender, reusable
The DiLumen Interventional Tool Mount ("DiLumen Im") is a dedicated accessory for the DiLumen C2 that facilitates use of the DiLumen C2 tool channels by holding these channels in a fixed position. The Tool Mount consists of the FISSO Holding System with an added, permanently attached stainless steel tool bar to firmly hold the DiLumen C2 tool channels in the clinician’s preferred orientation. The Tool Mount and holding system is attached to a standard surgical table rail using a rail clamp.
LUMENDI LLC
DiLumen Im
In Commercial Distribution

  • 00858836007003 ()
D-4000

  • Surgical instrument assist arm system, manually-adjusted
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