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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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2D Linear Probe - 03665134000103

Surface 2D probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam for Abdominal, Gynecology, Musculoskeletal, small organs, soft tissues, urology and vascular applications Frequencies: 7-15MHz Field of view 40 mm
KOELIS
K2DLN00
In Commercial Distribution

  • 03665134000530 ()
  • 03665134000103 ()


  • General-purpose ultrasound imaging system

2D Abdominal Probe - 03665134000097

Surface 2D probe (Convex) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam for Abdominal, Gynecology, Musculoskeletal, soft tissues, Urology and Vascular applications Frequencies: 2-5MHz Field of view 460° Radius 60 mm
KOELIS
K2DAB00
In Commercial Distribution

  • 03665134000523 ()
  • 03665134000097 ()


  • General-purpose ultrasound imaging system

3D Side-Fire Endocavity Probe - 03665134000080

Invasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3D mapping, for urology application. Frequencies: 4-9 MHz Field of view 72 mm Scanning angle 170°
KOELIS
K3DEL00
In Commercial Distribution

  • 03665134000516 ()
  • 03665134000080 ()


  • General-purpose ultrasound imaging system

3D End-Fire Endocavity Probe - 03665134000073

Invasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3D mapping, for urology and gynecology applications. Frequencies: 4-9 MHz Field of view 146° Scanning angle 90° Radius 10 mm
KOELIS
K3DEC00-2
In Commercial Distribution

  • 03665134000509 ()
  • 03665134000073 ()


  • General-purpose ultrasound imaging system

PEDIGUARD THREADED - 03662674000464

No Description
SPINEGUARD
DSG Threaded Shaft A LK - Ø4.5mm
In Commercial Distribution

  • 03662674000464 ()
D1TA1007

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000457

No Description
SPINEGUARD
DSG Threaded Shaft A LK - Ø5.5mm
In Commercial Distribution

  • 03662674000457 ()
D1TA1001

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000365

No Description
SPINEGUARD
DSG Threaded Shaft F - Ø4.0mm
In Commercial Distribution

  • 03662674000365 ()
D1TA0006

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000358

No Description
SPINEGUARD
DSG Threaded Shaft K - Ø5.5mm
In Commercial Distribution

  • 03662674000358 ()
D1TA0014

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000341

No Description
SPINEGUARD
DSG Threaded Shaft K - Ø4.5mm
In Commercial Distribution

  • 03662674000341 ()
D1TA0013

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000327

No Description
SPINEGUARD
DSG Threaded Shaft B - Ø4.5mm
In Commercial Distribution

  • 03662674000327 ()
D1TA0011

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000310

No Description
SPINEGUARD
DSG Sleeve #2
In Commercial Distribution

  • 03662674000310 ()
D1ST0002

  • Orthopaedic implantation sleeve, reusable

PEDIGUARD THREADED - 03662674000303

No Description
SPINEGUARD
DSG Threaded Shaft J - Ø4.5mm
In Commercial Distribution

  • 03662674000303 ()
D1TA0010

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000297

No Description
SPINEGUARD
DSG Threaded Shaft H - Ø5.5mm
In Commercial Distribution

  • 03662674000297 ()
D1TA0009

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000280

No Description
SPINEGUARD
DSG Threaded Shaft G - Ø5.0mm
In Commercial Distribution

  • 03662674000280 ()
D1TA0008

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000273

No Description
SPINEGUARD
DSG Threaded Shaft A - Ø4.5mm
In Commercial Distribution

  • 03662674000273 ()
D1TA0007

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000266

No Description
SPINEGUARD
DSG Technology Instrument Set - Lid
In Commercial Distribution

  • 03662674000266 ()
D1TT2001

  • Instrument tray, reusable

PEDIGUARD THREADED - 03662674000259

No Description
SPINEGUARD
DSG Technology Instrument Set - Base
In Commercial Distribution

  • 03662674000259 ()
D1TT1001

  • Instrument tray, reusable

PEDIGUARD THREADED - 03662674000242

No Description
SPINEGUARD
DSG Sleeve #1
In Commercial Distribution

  • 03662674000242 ()
D1ST0001

  • Orthopaedic implantation sleeve, reusable

PEDIGUARD THREADED - 03662674000235

No Description
SPINEGUARD
DSG Ratcheting Handle A
In Commercial Distribution

  • 03662674000235 ()
D1RH0001

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000228

No Description
SPINEGUARD
DSG Threaded Shaft C - Ø5.5mm
In Commercial Distribution

  • 03662674000228 ()
D1TA0003

  • Manual surgical rotary handpiece, reusable
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