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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
NXSTAGE MEDICAL, INC.
NX3094
Not in Commercial Distribution

  • 00842289101883 ()


  • Medical equipment clinical data interfacing software
No Description
BIOTRONIK SE & Co. KG
2.5
In Commercial Distribution

  • 04035479180461 ()
469464

  • Implantable cardiac device management application software
Optionally, the electrostimulator (SPM01M1) can require the combined use with the MySPM mobile application, as accessory of the Subject device. It allows to monitor the user and guide rehabilitation and training through specific protocols.
NCS LAB SRL
SPM01A1
In Commercial Distribution

  • 08051122040926 ()
SPM01A1

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
QuicklyPro-APP is a medical software that supports healthcare professionals, in general the physiotherapist, in managing the rehabilitation plan; in detail, it allows the patient at home to view and perform the exercises assigned to him by the physiotherapist, at the end of the exercises the results obtained are recorded and sent to the QP-Rehab platform where the physiotherapist can consult them.
QUICKLYPRO SRL
1.1.2
In Commercial Distribution

  • 08056999860035 ()


  • Biomechanical function analysis/rehabilitation software
Hearing device app
AMPLIFON SPA
5.0.2
In Commercial Distribution

  • 08059606110356 ()


  • Hearing aid/implant system remote control
No Description
APPLE INC.
Feature Version 1.x
In Commercial Distribution

  • 00190198909541 ()


  • Cardiopulmonary physiological parameter analysis software, professional-only
No Description
APPLE INC.
Feature Version 1.x
In Commercial Distribution

  • 00190198909534 ()


  • Cardiopulmonary physiological parameter analysis software, professional-only
CANISTER SUPPORT BRACKET TO ATTACH CANISTER DIRECTLY TO A VACUUM REGULATOR
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411001332 ()
  • 00704411001334 ()
443040415

  • General-purpose suction system, vacuum
It is an Orthosis for the hand bone, graphite color. Made of modern multilayer material (special velor tripled fabric (glued in a special way with polyurethane foam) with cotton terry cloth) and reinforced with a rigid wide profiled splint with an angle of 60 degrees to the hand relative to the forearm, located along the palm. Universal for the left and right hand, it can be used instead of a plaster splint.
REABILITIMED TOV
TUTOR-6K XSp Comfort
In Commercial Distribution

  • 04823097720189 ()

  • Child's age: from 2 to 5 years
TUTOR-6K XSp Comfort

  • Knee support orthosis
It is an orthosis for the shoulder and elbow joint, beige in color. Made of multilayer material (special velor triple-layered fabric (glued in a special way with polyurethane foam) with cotton terry cloth) and designed so that the two sleeves supporting the arm are easily adjusted in height using a textile fastener. Additionally equipped with a belt around the chest to press the arm to the body for its reliable fixation.
REABILITIMED TOV
RP-6K-M UNIp-1 Comfort
In Commercial Distribution

  • 04823097719510 ()

  • Child's age: from 2 to 5 years
RP-6K-M UNIp-1 Comfort

  • Elbow orthosis
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