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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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EX NEURO PATIENT TREATMENT KIT 3.0T W\O COIL SU w/PFK for 1 treatment PFK package served ETO-sterile
INSIGHTEC LTD
SET001117-SU (w/ PFK) EX NEURO PATIENT TREATMENT KIT 3.0T W\O COIL SU
In Commercial Distribution

  • 07290019402213 ()
SET001117-SU

  • Therapeutic oncological/gynaecological ultrasound system
ExAblate 2100/2100V1/2100V1-AR UPPER PELVIC COIL for MRI imaging during Body FUS treatments. Contains Upper and Lower part:
INSIGHTEC LTD
ASM000426-AA ExAblate 2100/2100V1/2100V1-AR UPPER PELVIC COIL
In Commercial Distribution

  • 07290015461504 ()
ASM000426-AA

  • Therapeutic oncological/gynaecological ultrasound system
System for non-invasive tumor ablation within head through Focal Ultrasound (FUS) treatment under Magnetiv Resonance (MR) guidance (i.e. MRgFUS).
INSIGHTEC LTD
4000 Type 1.0
In Commercial Distribution

  • 07290015461023 ()

  • Weight: 1350 Kilogram
EXABLATE 4000 Type 1.0

  • Therapeutic oncological/gynaecological ultrasound system
Special Bolus Needle for use with CODMAN 3000 series Drug Delivery System Straight Length 1 3/8inch (3.5 cm)
Medos International Sàrl
AP-04013-5
Not in Commercial Distribution

  • 20886704043727 ()
  • 10886704043720 ()
AP040135

  • Implantable intrathecal infusion pump, nonprogrammable
Eversense Insertion Tools Kit includes the Insertion Tool, Blunt Dissector, incision template and instructions for Sensor insertion and removal.
SENSEONICS, INCORPORATED
101973-009
Not in Commercial Distribution

  • 00817491021403 ()
N/A

  • Subcutaneous implantation kit, non-medicated
Eversense Insertion Tools Kit includes the Insertion Tool, Blunt Dissector, incision template and instructions for Sensor insertion and removal.
SENSEONICS, INCORPORATED
FG-8211-01-201
In Commercial Distribution

  • 00817491021397 ()
FG-8211-01-201

  • Subcutaneous implantation kit, non-medicated
For the detection of effector t cells that respond to stimulation by mycobacterium tuberculosis antigens esat-6 and cfp-10 and indicated for use as an aid in the diagnosis of m.Tuberculosis infection in conjunction with risk assesment, radiography and other medical diagnostic evaluations.
Oxford Immunotec, Inc.
TB.300
In Commercial Distribution

  • 15051716000305 ()
TB.300US

  • Mycobacterium tuberculosis complex species antigen IVD, kit, enzyme immunoassay (EIA)
For the detection of effector t cells that respond to stimulation by mycobacterium tuberculosis antigens esat-6 and cfp-10 and indicated for use as an aid in the diagnosis of M.Tuberculosis infection in conjunction with risk assessment, radiography and other medical diagnostic evaluations.
Oxford Immunotec, Inc.
TB.50
In Commercial Distribution

  • 15051716000046 ()
TB.50US

  • Mycobacterium tuberculosis complex species antigen IVD, kit, enzyme immunoassay (EIA)
For the detection of effector t cells that respond to stimulation by mycobacterium tuberculosis antigens esat-6 and cfp-10 and indicated for use as an aid in the diagnosis of m.Tuberculosis infection in conjunction with risk assesment, radiography and other medical diagnostic evaluations.
Oxford Immunotec, Inc.
TB.200
In Commercial Distribution

  • 15051716000008 ()
TB.200US

  • Mycobacterium tuberculosis complex species antigen IVD, kit, enzyme immunoassay (EIA)
Apligraf is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full thickness skin ulcers due to venous insufficience of greater than one month duration and which have not adequately responded to conventional ulcer therapy. Apligraf is also indicated for use with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers of greater than three weeks duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.
ORGANOGENESIS INC.
1
In Commercial Distribution

  • 00618474000008 ()


  • Skin regeneration template, human-/animal-derived
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