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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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No Description
DENTAL MANUFACTURING SPA
EVO 2 ST 6 LOWER
Not in Commercial Distribution

  • 28056865012906 ()
  • 08056865012810 ()
  • 18056865012817 ()
0120081

  • Resin artificial teeth
No Description
DENTAL MANUFACTURING SPA
EVO 2 ST 6 UPPER
Not in Commercial Distribution

  • 08056865012803 ()
  • 28056865012906 ()
  • 18056865012800 ()
0120080

  • Resin artificial teeth
Digital intra oral sensor for radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure.
TRIDENT SRL
Size 2
In Commercial Distribution

  • 08055060430412 ()

  • Width: 31.3 Millimeter
  • Length: 42.9 Millimeter
  • Height: 4.8 Millimeter
IS029-DL

  • Dental digital imaging sensor, intraoral
The Gloreha Professional 2 (GP2) is a neuromotor rehabilitation device designed to support recovery for patients with neuromuscular impairments. This electrically powered device mobilizes the metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints, aiding finger movement. Through an interactive virtual software program, GP2 combines motor therapy with visual and auditory stimuli. This targeted approach helps rehabilitate upper limb functionality by reinforcing motor patterns essential for daily tasks.
IDROGENET SRL
1
In Commercial Distribution

  • 08055713760019 ()
GP2

  • Virtual-display rehabilitation system, powered-support, upper-limb
The IceCaps are medical devices used as EEG electrodes. They are used by Healthcare Professionals on a patient in case of neurological disorders with a short or long-term EEG record (up to 72 hours). IceCap 2 shall be placed on patients weighing at least 10 kg (22.05 Ibs) and having a head circumference above 43 cm (16.93 inches). IceCap Neonate shall be placed on the head of babies, newborns and premature babies.
BIOSERENITY MEDICAL DEVICES GROUP
1001-01014-UN
In Commercial Distribution

  • 03615220003617 ()


  • Electroencephalographic electrode cap, single-use
crea.lign Opaker 2 A2 4 g
bredent GmbH & Co. KG
CLFHOP02
In Commercial Distribution

  • EBRECLFHOP029 ()
  • EBRECLFHOP020 ()
CLFHOP02

  • Dental veneer, professional
No Description
OVERFIBERS SRL
H-Endodontic Drill # 2
In Commercial Distribution

  • 08059388442782 ()
HED202

  • Rotary/reciprocating endodontic file/rasp, reusable
No Description
OVERFIBERS SRL
Over Post+ # 2
In Commercial Distribution

  • 08059388443239 ()
  • 08059388441235 ()
PP702

  • Root canal post, preformed
No Description
OVERFIBERS SRL
Prosthetic Drill # 2
In Commercial Distribution

  • 08059388440450 ()
PD102

  • Rotary/reciprocating endodontic file/rasp, reusable
No Description
OVERFIBERS SRL
Polygon Drill # 2
In Commercial Distribution

  • 08059388440382 ()
PYD02

  • Rotary/reciprocating endodontic file/rasp, reusable
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