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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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LUMIX C.P.S. - 08057949170099

LASER THERAPY UNIT LUMIX C.P.S. with 3 WAVELENGTH (650nm+810nm+910nm)
FISIOLINE SRL
LUMIX C.P.S.1
In Commercial Distribution

  • 08057949170099 ()

  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 810 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 10 Millimeter
LCPS702

  • Skin laser scanner

LUMIX C.P.S. - 08057949170082

LASER THERAPY UNIT LUMIX C.P.S. with 4 WAVELENGTH (650nm+810nm+910nm+980nm)
FISIOLINE SRL
LUMIX C.P.S.4
In Commercial Distribution

  • 08057949170082 ()

  • Lumen/Inner Diameter: 10 Millimeter
  • Lumen/Inner Diameter: 980 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 810 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
LCPS701

  • Skin laser scanner

LUMIX C.P.S. - 08057949170075

LASER THERAPY UNIT LUMIX C.P.S. with 4 WAVELENGTH (650nm+810nm+910nm+1064nm)
FISIOLINE SRL
LUMIX C.P.S.5
In Commercial Distribution

  • 08057949170075 ()

  • Lumen/Inner Diameter: 10 Millimeter
  • Lumen/Inner Diameter: 1064 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 810 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
LCPS6

  • Skin laser scanner

LUMIX C.P.S. - 08057949170068

LASER THERAPY UNIT LUMIX C.P.S. with 4 WAVELENGTH (650nm+810nm+910nm+1064nm)
FISIOLINE SRL
LUMIX C.P.S.5
In Commercial Distribution

  • 08057949170068 ()

  • Lumen/Inner Diameter: 10 Millimeter
  • Lumen/Inner Diameter: 1064 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 810 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
LCPS5

  • Skin laser scanner

LUMIX 250 - 08057949170044

LASER THERAPY UNIT LUMIX 250 TOUCH SCREEN with 2 WAVELENGTH (650nm+910nm) AVERAGE POWER 5W
FISIOLINE SRL
LUMIX 250
In Commercial Distribution

  • 08057949170044 ()

  • Lumen/Inner Diameter: 20 Millimeter
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
LUMIX250R2

  • Skin laser scanner

LUMIX 100 - 08057949170037

LASER THERAPY UNIT LUMIX 100 TOUCH SCREEN with 2 WAVELENGTH (650nm+910nm) AVERAGE POWER 2W
FISIOLINE SRL
LUMIX 100
In Commercial Distribution

  • 08057949170037 ()

  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 20 Millimeter
LUMIX100R2

  • Skin laser scanner

LUMIX 2 - 08057949170020

LASER THERAPY UNIT LUMIX 2 with 2 WAVELENGTH
FISIOLINE SRL
LUMIX 2
In Commercial Distribution

  • 08057949170020 ()

  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 10 Millimeter
L2PC02

  • Skin laser scanner

LUMIX 2 - 08057949170013

LASER THERAPY UNIT LUMIX 2 TOUCH SCREEN with 2 WAVELENGTH (650nm+910nm)
FISIOLINE SRL
LUMIX 2
In Commercial Distribution

  • 08057949170013 ()

  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 10 Millimeter
L2PC01

  • Skin laser scanner

DENTAL IRRIGATION KIT - 08057949141471

No Description
ANCHIPLAST SRL
6415
In Commercial Distribution

  • 08057949141488 ()
  • 08057949141471 ()
  • 08057949141495 ()
6415

  • Surgical irrigation tubing set, single-use

MEDICAL IRRIGATION KIT - 08057949140863

No Description
ANCHIPLAST SRL
6461
In Commercial Distribution

  • 08057949140870 ()
  • 08057949140863 ()
  • 08057949140856 ()
6461

  • Surgical irrigation tubing set, single-use

DENTAL IRRIGATION KIT - 08057949140672

No Description
ANCHIPLAST SRL
6448
In Commercial Distribution

  • 08057949140689 ()
  • 08057949140672 ()
  • 08057949142089 ()
6448

  • Surgical irrigation tubing set, single-use

DENTAL IRRIGATION KIT - 08057949140573

No Description
ANCHIPLAST SRL
6444
In Commercial Distribution

  • 08057949140580 ()
  • 08057949140573 ()
  • 08057949142003 ()
6444

  • Surgical irrigation tubing set, single-use

DENTAL IRRIGATION KIT - 08057949140511

No Description
ANCHIPLAST SRL
6435
In Commercial Distribution

  • 08057949140528 ()
  • 08057949140511 ()
  • 08057949141976 ()
6435

  • Surgical irrigation tubing set, single-use

Dental irrigation kit - 08057949140450

No Description
ANCHIPLAST SRL
6415
In Commercial Distribution

  • 08057949140467 ()
  • 08057949140450 ()
  • 08057949141914 ()
6415

  • Surgical irrigation tubing set, single-use

NECKLITE - 08057592700131

No Description
FLAMOR SRL
BLK
In Commercial Distribution

  • 08057592700131 ()


  • Cervical spine collar, reusable

NECKLITE - 08057592700100

No Description
FLAMOR SRL
BLUE / SC
In Commercial Distribution

  • 08057592700100 ()


  • Cervical spine collar, reusable

HYBRIBOARD - 08057592700087

The sides of the Hybriboard do not expose the patient to the risk of secondary damage caused, as is the case with basket stretchers, by the vertical walls of the stretcher being 20-25cm high.
FLAMOR SRL
SPORT
In Commercial Distribution

  • 08057592700087 ()


  • Portable stretcher

TOURNIK-IT - 08057592700025

TOURNIK-IT is a hemostasis system used to control bleeding
FLAMOR SRL
TK-00
In Commercial Distribution

  • 08057592700025 ()


  • Venous tourniquet, reusable

CARTUCCIA CON 16 POZZETTI/16-WELLS CARTRIDGE - 08057507430023

PCR Cartridge.
HYRIS SRL
HyCT16.01-25
In Commercial Distribution

  • 08057507430023 ()
HyCT16.01-25

  • Instrument/analyser specimen/reagent container carrier IVD

PLEXR PLUS - 08057506440085

No Description
GMV SRL
PLEXR PLUS L
In Commercial Distribution

  • 08057506440085 ()


  • Thermo-mechanical skin surface treatment system

Endorail Set - 08057502310108

Endorail includes two components to be used in combination called: Endorail Set and Endorail System. Endorail Set is disposable and includes the following elements: • Endorail Balloon Guide (EBG), • Endorail Solution Syringe (ESS), • Endorail Powder (EP), • Spike. Before the procedure, the operator prepares the syringe containing the ferromagnetic fluid using the ESS, the spike and the EP. The EBG is a balloon catheter that can be introduced as needed through the endoscope instrument channel during the colonoscopy, if the procedure becomes challenging. Endorail Set does not require to be pre-mounted and does not interfere with the normal examination process. The EBG is advanced beyond the colonoscope tip where the balloon is filled with the ferromagnetic fluid and magnetically anchored with the Endorail Handpiece (EH) placed on the patient’s abdomen. Once anchored, the colonoscope can be straightened and guided along the catheter. Afterward the EBG can be unlocked, deflated and retrieved.
ENDOSTART SRL
ESETGEN2V02A
In Commercial Distribution

  • 08057502310115 ()
  • 08057502310108 ()
ESETGEN2V02A

  • Gastrointestinal endoscope manipulation magnetic balloon catheter

Endorail System - 08057502310092

Endorail includes two components to be used in combination called: Endorail Set and Endorail System. Endorail System is reusable and includes the following elements: • Endorail Handpiece (EH), • Endorail Cart (EC). Before the procedure, the operator prepares the syringe containing the ferromagnetic fluid using the Endorail Solution Syringe (ESS), the spike and the Endorail Powder (EP). The Endorail Balloon Guide (EBG) is a balloon catheter that can be introduced as needed through the endoscope instrument channel during the colonoscopy, if the procedure becomes challenging. Endorail Set does not require to be pre-mounted and does not interfere with the normal examination process. The EBG is advanced beyond the colonoscope tip where the balloon is filled with the ferromagnetic fluid and magnetically anchored with the Endorail Handpiece (EH) placed on the patient’s abdomen. Once anchored, the colonoscope can be straightened and guided along the catheter. Afterward the EBG can be unlocked, deflated and retrieved.
ENDOSTART SRL
ESYSTEMGEN2V01A
In Commercial Distribution

  • 08057502310092 ()
ESYSTEMGEN2V01A

  • Gastrointestinal endoscope manipulation external magnet

PicoMix Gun - 08058964727855

No Description
G21 SRL
900210
In Commercial Distribution

  • 08058964727855 ()


  • Orthopaedic cement preparation/delivery kit

PicoMix Syringe - 08058964727848

No Description
G21 SRL
900209
In Commercial Distribution

  • 08058964727848 ()


  • Orthopaedic cement preparation/delivery kit

PicoMix Bowl - 08058964727831

No Description
G21 SRL
900211
In Commercial Distribution

  • 08058964727831 ()


  • Orthopaedic cement preparation/delivery kit

Winch Kyphoplasty Bilateral Kit 20 mm - 08058964727817

No Description
G21 SRL
900018B
In Commercial Distribution

  • 08058964727817 ()


  • Balloon kyphoplasty kit

Winch Kyphoplasty Bilateral Kit 8G 20 mm - 08058964727794

No Description
G21 SRL
900208B
In Commercial Distribution

  • 08058964727794 ()


  • Balloon kyphoplasty kit

Winch Kyphoplasty Kit 8G 20 mm - 08058964727787

No Description
G21 SRL
900208
In Commercial Distribution

  • 08058964727787 ()


  • Balloon kyphoplasty kit

Winch Kyphoplasty Bilateral Kit 8G 15 mm - 08058964727770

No Description
G21 SRL
900207B
In Commercial Distribution

  • 08058964727770 ()


  • Balloon kyphoplasty kit

Winch Kyphoplasty Kit 8G 15 mm - 08058964727763

No Description
G21 SRL
900207
In Commercial Distribution

  • 08058964727763 ()


  • Balloon kyphoplasty kit

Keyfix Bone Cement Filler Cannula 9G - 08058964727732

No Description
G21 SRL
900206
In Commercial Distribution

  • 08058964727732 ()


  • Vertebral body cement cannula

Keyfix direct access needle 8G - 08058964727725

No Description
G21 SRL
900205
In Commercial Distribution

  • 08058964727725 ()


  • Vertebral body cement cannula

Keyfix bone drill 9G - 08058964727718

No Description
G21 SRL
900204
In Commercial Distribution

  • 08058964727718 ()


  • Bone access channel kit

EasyWinch 20 mm - 08058964727596

No Description
G21 SRL
900199
In Commercial Distribution

  • 08058964727596 ()


  • Balloon kyphoplasty kit

EasyWinch 15 mm - 08058964727589

No Description
G21 SRL
900198
In Commercial Distribution

  • 08058964727589 ()


  • Balloon kyphoplasty kit

SpaceFlex Knee - 08058964727039

Orthopedic bone cement modular spacer for temporary knee prosthesis
G21 SRL
900189 80
In Commercial Distribution

  • 08058964727039 ()


  • Orthopaedic cement spacer mould

SpaceFlex Knee - 08058964726940

No Description
G21 SRL
900189 70
In Commercial Distribution

  • 08058964726940 ()


  • Orthopaedic cement spacer mould

SpaceFlex Knee - 08058964726933

No Description
G21 SRL
900189 60
In Commercial Distribution

  • 08058964726933 ()


  • Orthopaedic cement spacer mould

SpaceFlex Hip - 08058964726902

Disposable custom modular spacer mold
G21 SRL
900005 15
In Commercial Distribution

  • 08058964726902 ()


  • Orthopaedic cement spacer mould

SpaceFlex Hip - 08058964726896

Disposable custom modular spacer mold
G21 SRL
900005 13
In Commercial Distribution

  • 08058964726896 ()


  • Orthopaedic cement spacer mould
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