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

  • 03662674000464 ()
D1TA1007

  • Manual surgical rotary handpiece, reusable
No Description
SPINEGUARD
DSG Threaded Shaft A LK - Ø5.5mm
In Commercial Distribution

  • 03662674000457 ()
D1TA1001

  • Manual surgical rotary handpiece, reusable
No Description
SPINEGUARD
DSG Threaded Shaft F - Ø4.0mm
In Commercial Distribution

  • 03662674000365 ()
D1TA0006

  • Manual surgical rotary handpiece, reusable
No Description
SPINEGUARD
DSG Threaded Shaft K - Ø5.5mm
In Commercial Distribution

  • 03662674000358 ()
D1TA0014

  • Manual surgical rotary handpiece, reusable
No Description
SPINEGUARD
DSG Threaded Shaft K - Ø4.5mm
In Commercial Distribution

  • 03662674000341 ()
D1TA0013

  • Manual surgical rotary handpiece, reusable
No Description
SPINEGUARD
DSG Threaded Shaft B - Ø4.5mm
In Commercial Distribution

  • 03662674000327 ()
D1TA0011

  • Manual surgical rotary handpiece, reusable
No Description
SPINEGUARD
DSG Sleeve #2
In Commercial Distribution

  • 03662674000310 ()
D1ST0002

  • Orthopaedic implantation sleeve, reusable
No Description
SPINEGUARD
DSG Threaded Shaft J - Ø4.5mm
In Commercial Distribution

  • 03662674000303 ()
D1TA0010

  • Manual surgical rotary handpiece, reusable
No Description
SPINEGUARD
DSG Threaded Shaft H - Ø5.5mm
In Commercial Distribution

  • 03662674000297 ()
D1TA0009

  • Manual surgical rotary handpiece, reusable
No Description
SPINEGUARD
DSG Threaded Shaft G - Ø5.0mm
In Commercial Distribution

  • 03662674000280 ()
D1TA0008

  • Manual surgical rotary handpiece, reusable
No Description
SPINEGUARD
DSG Threaded Shaft A - Ø4.5mm
In Commercial Distribution

  • 03662674000273 ()
D1TA0007

  • Manual surgical rotary handpiece, reusable
No Description
SPINEGUARD
DSG Technology Instrument Set - Lid
In Commercial Distribution

  • 03662674000266 ()
D1TT2001

  • Instrument tray, reusable
No Description
SPINEGUARD
DSG Technology Instrument Set - Base
In Commercial Distribution

  • 03662674000259 ()
D1TT1001

  • Instrument tray, reusable
No Description
SPINEGUARD
DSG Sleeve #1
In Commercial Distribution

  • 03662674000242 ()
D1ST0001

  • Orthopaedic implantation sleeve, reusable
No Description
SPINEGUARD
DSG Ratcheting Handle A
In Commercial Distribution

  • 03662674000235 ()
D1RH0001

  • Manual surgical rotary handpiece, reusable
No Description
SPINEGUARD
DSG Threaded Shaft C - Ø5.5mm
In Commercial Distribution

  • 03662674000228 ()
D1TA0003

  • Manual surgical rotary handpiece, reusable
No Description
SPINEGUARD
DSG Threaded Shaft B - Ø5.5mm
In Commercial Distribution

  • 03662674000211 ()
D1TA0002

  • Manual surgical rotary handpiece, reusable
No Description
SPINEGUARD
DSG Threaded Shaft A - Ø5.5mm
In Commercial Distribution

  • 03662674000204 ()
D1TA0001

  • Manual surgical rotary handpiece, reusable
No Description
SPINEGUARD
CANNULATES PEDIGUARD CANNULA 120mm
In Commercial Distribution

  • 03662674000167 ()

  • Length: 120 Millimeter
P2CN1110

  • Bone awl, reusable
No Description
SPINEGUARD
CANNULATED PEDIGUARD STARTER STYLET - TROCAR 120mm
In Commercial Distribution

  • 03662674000143 ()

  • Length: 120 Millimeter
P2ST1160

  • Bone awl, reusable
No Description
SPINEGUARD
CANNULATED PEDIGUARD STARTER STYLET - BEVEL 120mm
In Commercial Distribution

  • 03662674000136 ()

  • Length: 120 Millimeter
P2ST1150

  • Bone awl, reusable
No Description
SPINEGUARD
CANNULATED PEDIGUARD STARTER STYLET - TROCAR
In Commercial Distribution

  • 03662674000105 ()
P2ST1060

  • Bone awl, reusable
No Description
SPINEGUARD
CANNULATED PEDIGUARD STARTER STYLET - BEVEL
In Commercial Distribution

  • 03662674000099 ()
P2ST1050

  • Bone awl, reusable
No Description
SPINEGUARD
CANNULATED PEDIGUARD CANNULA 160mm
In Commercial Distribution

  • 03662674000082 ()

  • Length: 160 Millimeter
P2CN1010

  • Bone awl, reusable
No Description
FIM MEDICAL
Q13
In Commercial Distribution

  • 03760253450003 ()


  • Pulmonary function analysis system, adult
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
Sulcular opening paste (x20 capsules).
PRODUITS DENTAIRES PIERRE ROLLAN
EXPASYL
In Commercial Distribution

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

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

  • 03760243009952 ()
  • 03760243000539 ()
201668

  • Surgical mist irrigation tip
Disposable single use tips for air/water syringe
PRODUITS DENTAIRES PIERRE ROLLAN
RISKONTROL
In Commercial Distribution

  • 03760243009921 ()
  • 03760243000508 ()
201665

  • Surgical mist irrigation tip
Disposable single use tips for air/water syringe.
PRODUITS DENTAIRES PIERRE ROLLAN
RISKONTROL
In Commercial Distribution

  • 03760243009853 ()
  • 03760243000430 ()
201700

  • Surgical mist irrigation tip
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
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
No Description
AD REM TECHNOLOGY
2.1
In Commercial Distribution

  • 03701084900022 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
AD REM TECHNOLOGY
8x13 OVAL
In Commercial Distribution

  • 03701084900008 ()


  • Transcutaneous electrical stimulation electrode, single-use
No Description
AD REM TECHNOLOGY
2.1
In Commercial Distribution

  • 03701084900039 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
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