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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

PEDIGUARD THREADED - 03662674000211

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

  • 03662674000211 ()
D1TA0002

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000204

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

  • 03662674000204 ()
D1TA0001

  • Manual surgical rotary handpiece, reusable

CANNULATED PEDIGUARD - 03662674000167

No Description
SPINEGUARD
CANNULATES PEDIGUARD CANNULA 120mm
In Commercial Distribution

  • 03662674000167 ()

  • Length: 120 Millimeter
P2CN1110

  • Bone awl, reusable

CANNULATED PEDIGUARD - 03662674000143

No Description
SPINEGUARD
CANNULATED PEDIGUARD STARTER STYLET - TROCAR 120mm
In Commercial Distribution

  • 03662674000143 ()

  • Length: 120 Millimeter
P2ST1160

  • Bone awl, reusable

CANNULATED PEDIGUARD - 03662674000136

No Description
SPINEGUARD
CANNULATED PEDIGUARD STARTER STYLET - BEVEL 120mm
In Commercial Distribution

  • 03662674000136 ()

  • Length: 120 Millimeter
P2ST1150

  • Bone awl, reusable

CANNULATED PEDIGUARD - 03662674000105

No Description
SPINEGUARD
CANNULATED PEDIGUARD STARTER STYLET - TROCAR
In Commercial Distribution

  • 03662674000105 ()
P2ST1060

  • Bone awl, reusable

CANNULATED PEDIGUARD - 03662674000099

No Description
SPINEGUARD
CANNULATED PEDIGUARD STARTER STYLET - BEVEL
In Commercial Distribution

  • 03662674000099 ()
P2ST1050

  • Bone awl, reusable

CANNULATED PEDIGUARD - 03662674000082

No Description
SPINEGUARD
CANNULATED PEDIGUARD CANNULA 160mm
In Commercial Distribution

  • 03662674000082 ()

  • Length: 160 Millimeter
P2CN1010

  • Bone awl, reusable

Spirolyser - 03760253450003

No Description
FIM MEDICAL
Q13
In Commercial Distribution

  • 03760253450003 ()


  • Pulmonary function analysis system, adult

Expasyl cannulas - 03760243000720

Expasyl straight application cannulas x40 for EXPASYL paste (sulcular opening paste).
PRODUITS DENTAIRES PIERRE ROLLAN
EXPASYL
In Commercial Distribution

  • 03760243009822 ()
  • 03760243000720 ()
261040

  • Dental material injection cannula, single-use

EXPASYL x20 - 03760243000706

Sulcular opening paste (x20 capsules).
PRODUITS DENTAIRES PIERRE ROLLAN
EXPASYL
In Commercial Distribution

  • 03760243009808 ()
  • 03760243000706 ()
  • 03760243007026 ()
261030

  • Gingival retraction kit

Total protec by RISKONTROL - 03760243000553

Disposable single use tips with sheath for air/water syringe
PRODUITS DENTAIRES PIERRE ROLLAN
RISKONTROL
In Commercial Distribution

  • 03760243000553 ()
  • 03760243009976 ()
201751

  • Surgical mist irrigation tip

Classic by RISKONTROL - 03760243000539

Disposable single use tips for air/water syringe.
PRODUITS DENTAIRES PIERRE ROLLAN
RISKONTROL
In Commercial Distribution

  • 03760243009952 ()
  • 03760243000539 ()
201668

  • Surgical mist irrigation tip

Classic by RISKONTROL - 03760243000508

Disposable single use tips for air/water syringe
PRODUITS DENTAIRES PIERRE ROLLAN
RISKONTROL
In Commercial Distribution

  • 03760243009921 ()
  • 03760243000508 ()
201665

  • Surgical mist irrigation tip

Art by RISKONTROL - 03760243000430

Disposable single use tips for air/water syringe.
PRODUITS DENTAIRES PIERRE ROLLAN
RISKONTROL
In Commercial Distribution

  • 03760243009853 ()
  • 03760243000430 ()
201700

  • Surgical mist irrigation tip

ADAPTATER RISKONTROL LU INOX - 03760243000263

The RISKONTROL adapter allows the use of the RISKONTROL disposable tips onto the air/water syringes.
PRODUITS DENTAIRES PIERRE ROLLAN
RISKONTROL
In Commercial Distribution

  • 03760243000263 ()
200150

  • Dental delivery system irrigation handpiece

ADAPTATER RISKONTROL DCI - 03760243000089

The RISKONTROL adapter allows the use of the RISKONTROL disposable tips onto the air/water syringes.
PRODUITS DENTAIRES PIERRE ROLLAN
RISKONTROL
In Commercial Distribution

  • 03760243000089 ()
200152

  • Dental delivery system irrigation handpiece

VEINOPLUS DVT - 03701084900022

No Description
AD REM TECHNOLOGY
2.1
In Commercial Distribution

  • 03701084900022 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system

VEINOPLUS PACK - 03701084900008

No Description
AD REM TECHNOLOGY
8x13 OVAL
In Commercial Distribution

  • 03701084900008 ()


  • Transcutaneous electrical stimulation electrode, single-use

VEINOPLUS SPORT - 03701084900039

No Description
AD REM TECHNOLOGY
2.1
In Commercial Distribution

  • 03701084900039 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
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