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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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ORION System - 03700383510031

Electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging.
BIZLINK ROBOTIC SOLUTIONS FRANCE S.A.S.
1SOPT00005
In Commercial Distribution

  • 03700383510031 ()
1SOPT00005

  • Proton therapy system robotic patient positioner

ORION System - 03700383510017

Electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging.
BIZLINK ROBOTIC SOLUTIONS FRANCE S.A.S.
1SOPT00003
In Commercial Distribution

  • 03700383510017 ()
1SOPT00003

  • Proton therapy system robotic patient positioner

ORION System - 03700383510000

Electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging.
BIZLINK ROBOTIC SOLUTIONS FRANCE S.A.S.
1SOPT00002
In Commercial Distribution

  • 03700383510000 ()
1SOPT00002

  • Proton therapy system robotic patient positioner

Direct A1c Reagent Kit - 03661540304675

For the quantitative determination of Hemoglobin A1c (HBA1c) in human blood.
ELITECHGROUP INC.
55370
In Commercial Distribution

  • 03661540304675 ()
55370

  • Glycated haemoglobin (HbA1c) IVD, reagent

VISICOIL - B887VC110030PL0

1.10mm x 3.0cm VISICOIL loaded in an 17 gauge brachytherapy needle.
Izi Medical Products, LLC
VC-110-030-PL
In Commercial Distribution

  • B887VC110030PL0 ()
VC-110-030-PL

  • Radiological image marker, implantable

Cinch™ - M595S463S0

Quick Cinch™ Heavy Body in Split-Cartridge System (4-Cartridges & Mixing Tips)
PARKELL, INC.
S463S
Not in Commercial Distribution

  • M595S463S1 ()
  • M595S463S0 ()
S463S

  • Silicone dental impression material

SPORVIEW 10 HOUR STEAM SCBI - 10732224721481

For use in biologically monitoring gravity displacement and dynamic-air-removal steam sterilizers.
SPS Medical Supply Corp.
SVT-050
In Commercial Distribution

  • 10732224721481 ()
  • 00732224721484 ()
SVT-050

  • Biological sterilization indicator

Luvena - 00899655002206

Luvena Vaginal Moisturizer & Lubricant - Sample - 1 pre-filled applicator in unit carton
LACLEDE, INC.
Vaginal Moisturizer & Lubricant sample
In Commercial Distribution

  • 00899655002206 ()


  • Sexual lubricant

DELTAVEN - 08032248385627

Safety IV Catheter in PUR with closed system and detachable cap
DELTA MED SPA
3856272
In Commercial Distribution

  • 58032248385622 ()
  • 38032248385628 ()
  • 08032248385627 ()

  • Gauge 16
  • Outer Diameter: 1.75 Millimeter
  • Length: 32 Millimeter


  • Peripheral vascular catheter

DELTAVEN - 08032248384736

Safety I.V Catheter in PUR with closed system and detachable stopcock
DELTA MED SPA
3847372
In Commercial Distribution

  • 58032248384731 ()
  • 38032248384737 ()
  • 08032248384736 ()

  • Gauge 18
  • Outer Diameter: 1.3 Millimeter
  • Length: 45 Millimeter


  • Peripheral vascular catheter
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