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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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REDUCTION POLYAXIAL SCREWDRIVER, LOCKING
ALPHATEC SPINE, INC.
16015-03
In Commercial Distribution

  • 00190376146614 ()


  • Surgical screwdriver, reusable
MIS Rod Inserter Locking Driver
ALPHATEC SPINE, INC.
16130
In Commercial Distribution

  • 00190376146515 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Pistol Compressor Final Driver
ALPHATEC SPINE, INC.
16144
In Commercial Distribution

  • 00190376139623 ()


  • Surgical screwdriver, reusable
MIS Final Driver
ALPHATEC SPINE, INC.
16138
In Commercial Distribution

  • 00190376139616 ()


  • Surgical screwdriver, reusable
No Description
HPF SRL
H0010200099
In Commercial Distribution

  • 08057968712546 ()


  • Surgical screwdriver, reusable
No Description
HPF SRL
H0010150099
In Commercial Distribution

  • 08057968712539 ()


  • Surgical screwdriver, reusable
No Description
HPF SRL
H0150005099
In Commercial Distribution

  • 08057968712522 ()


  • Surgical screwdriver, reusable
No Description
HPF SRL
H0030158599
In Commercial Distribution

  • 08057968712508 ()


  • Surgical screwdriver, reusable
No Description
HPF SRL
H0150005599
In Commercial Distribution

  • 08057968712492 ()


  • Surgical screwdriver, reusable
No Description
HPF SRL
H0010150599
In Commercial Distribution

  • 08057968712485 ()


  • Surgical screwdriver, reusable
No Description
HPF SRL
H0150004599
In Commercial Distribution

  • 08057968712478 ()


  • Surgical screwdriver, reusable
No Description
HPF SRL
H0150006599
In Commercial Distribution

  • 08057968712454 ()


  • Surgical screwdriver, reusable
No Description
HPF SRL
H0150006099
In Commercial Distribution

  • 08057968712447 ()


  • Surgical screwdriver, reusable
No Description
BRM EXTREMITIES SRL
Solid screwdriver Hex 2.5
In Commercial Distribution

  • 08057717553260 ()
STVI2ES025P

  • Surgical screwdriver, reusable
No Description
BRM EXTREMITIES SRL
Solid screwdriver Hex 2.0
In Commercial Distribution

  • 08057717553239 ()
STVI2ES020P

  • Surgical screwdriver, reusable
No Description
BRM EXTREMITIES SRL
Solid screwdriver Hex 1.7
In Commercial Distribution

  • 08057717553208 ()
STVI2ES017P

  • Surgical screwdriver, reusable
The Elite iQ™ workstation is a dual wavelength system that delivers laser energy in both the Nd:YAG (1064-nm) and Alexandrite (755-nm) wavelengths. Through various spot sizes, fluences and repetition rates, the system offers hair removal treatment and aesthetic treatments across all skin types. An Alexandrite standalone workstation is also available for purchase (M122D1 model). The Elite iQ delivers the laser energy through a lens-coupled optical fiber with a wide range of interchangeable, quick-release laser handpieces with electronic spot recognition. The Elite iQ also includes the Skintel® Melanin Reader for objective measurement of the melanin content of skin. The locking casters allow this stand-alone laser system to be secured in place, as well as to be conveniently moved or transported. When not in use, handpiece components and other system components can be stowed in the storage area located in the side drawer. All system connections, such as the foot switch and remote interlock connections, are located on the rear of the laser. This includes all applicable device labels. User-selectable controls and functions are located on the front of the laser. Elite iQ software features include a Windows® operating system, LCD touch screen and a state-of-the-art graphic user interface.
EL.EN. SPA
M122D1
In Commercial Distribution

  • 08057017760467 ()
M122D1

  • Multi-modality skin surface treatment system
The Elite iQ™ workstation is a dual wavelength system that delivers laser energy in both the Nd:YAG (1064-nm) and Alexandrite (755-nm) wavelengths. Through various spot sizes, fluences and repetition rates, the system offers hair removal treatment and aesthetic treatments across all skin types. An Alexandrite standalone workstation is also available for purchase. The Elite iQ delivers the laser energy through a lens-coupled optical fiber with a wide range of interchangeable, quick-release laser handpieces with electronic spot recognition. The Elite iQ also includes the Skintel® Melanin Reader for objective measurement of the melanin content of skin. The locking casters allow this stand-alone laser system to be secured in place, as well as to be conveniently moved or transported. When not in use, handpiece components and other system components can be stowed in the storage area located in the side drawer. All system connections, such as the foot switch and remote interlock connections, are located on the rear of the laser. This includes all applicable device labels. User-selectable controls and functions are located on the front of the laser. Elite iQ software features include a Windows® operating system, LCD touch screen and a state-of-the-art graphic user interface.
EL.EN. SPA
M122B1
In Commercial Distribution

  • 08057017760450 ()
M122B1

  • Multi-modality skin surface treatment system
Contra angle driver TAD key
H.D.C. SRL
DLM-3134
In Commercial Distribution

  • 08057013140102 ()
DLM-3134

  • Surgical screwdriver, reusable
Stainless steel mallet
MC BIO SRL
9100340
In Commercial Distribution

  • 08056992093058 ()


  • Surgical mallet
No Description
CITIEFFE SRL
Screwdriver for Rondo' screws ø6.5-7.5mm
In Commercial Distribution

  • 08056711928753 ()
VT-97020

  • Surgical screwdriver, reusable
No Description
CITIEFFE SRL
Hexagonal screwdriver shaft, 3.5mm AO connection
In Commercial Distribution

  • 08056711928579 ()
VP-92035

  • Surgical screwdriver, reusable
No Description
CITIEFFE SRL
Screwdriver for Rondo' screws ø5mm
In Commercial Distribution

  • 08056711928562 ()
VP-92030

  • Surgical screwdriver, reusable
No Description
CITIEFFE SRL
Hexagonal screwdriver shaft, 2.5mm AO connection
In Commercial Distribution

  • 08056711928548 ()
VP-92015

  • Surgical screwdriver, reusable
No Description
CITIEFFE SRL
Screwdriver for Rondo' screws ø3-4mm
In Commercial Distribution

  • 08056711928524 ()
VP-92010

  • Surgical screwdriver, reusable
No Description
CITIEFFE SRL
Cardanic screwdriver long shaft, 3.5mm
In Commercial Distribution

  • 08056711928456 ()
EBA-5348

  • Surgical screwdriver, reusable
No Description
CITIEFFE SRL
Wrench, 8mm Hudson coupling
In Commercial Distribution

  • 08056711927756 ()
EBA-5352

  • Surgical screwdriver, reusable
No Description
CITIEFFE SRL
Flexible screwdriver, 3.5mm
In Commercial Distribution

  • 08056711920405 ()
EBA-5344

  • Surgical screwdriver, reusable
Diaphyseal Screwdriver
INTRAUMA SPA
SE221
In Commercial Distribution

  • 08056693001888 ()
SE221

  • Surgical screwdriver, reusable
7,0mm Assembly Hex Screwdriver
INTRAUMA SPA
SE205
In Commercial Distribution

  • 08056693001727 ()
SE205

  • Surgical screwdriver, reusable
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