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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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strap used for attaching the stereotactic frame to patient head during neuro FUS clinical treatment
INSIGHTEC LTD
Neuro Frame Attachment Strap
In Commercial Distribution

  • 07290015461337 ()
MEC001647

  • Therapeutic oncological/gynaecological ultrasound system
multi use Stereotactic Frame Set for fixing the skull position during neuro FUS clinical treatment
INSIGHTEC LTD
Neuro Stereotactic Frame Set
In Commercial Distribution

  • 07290015461283 ()
SET400168

  • Therapeutic oncological/gynaecological ultrasound system
The MP Diagnostics HTLV Blot 2.4 is a qualitative enzyme immunoassay intended for confirming the presence of and differentiating antibodies to HTLV-I and HTLV-II in human serum and plasma. It is intended for use as a supplemental (additional, more specific) test for human serum and plasma samples with repeatedly reactive results by an FDA licensed HTLV-I/II donor screening test. The MP Diagnostics HTLV Blot 2.4 is intended for use in a manual mode or a semi-automated mode using the MP Diagnostics AutoBlot System 20. This test is not intended for use in medical diagnosis.
MP BIOMEDICALS ASIA PACIFIC PTE. LTD.
36 test
In Commercial Distribution

  • 08887581000016 ()
07110888036

  • Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, immunoblot
The MP Diagnostics HTLV Blot 2.4 is a qualitative enzyme immunoassay intended for confirming the presence of and differentiating antibodies to HTLV-I and HTLV-II in human serum and plasma. It is intended for use as a supplemental (additional, more specific) test for human serum and plasma samples with repeatedly reactive results by an FDA licensed HTLV-I/II donor screening test. The MP Diagnostics HTLV Blot 2.4 is intended for use in a manual mode or a semi-automated mode using the MP Diagnostics AutoBlot System 20. This test is not intended for use in medical diagnosis.
MP BIOMEDICALS ASIA PACIFIC PTE. LTD.
18 test
In Commercial Distribution

  • 08887581000009 ()
0711088018

  • Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, immunoblot
The Home Access Health Corporation HIV-1 Standard Test System is intended for use by persons to anonymously determine if antibodies to HIV-1 (Human Immunodeficiency Virus, Type-1) can be detected in their blood. It is intended for home use by persons with little or no experience in obtaining blood spot samples for medical testing. The kit contains all components necessary to collect and send your blood spot sample to Home Access laboratory for testing.
Home Access Health Corporation
21
In Commercial Distribution

  • M769HIVSTANDARD211 ()


  • Capillary blood collection set, home-use
The Home Access Health Corporation HIV-1 Standard Test System is intended for use by persons to anonymously determine if antibodies to HIV-1 (Human Immunodeficiency Virus, Type-1) can be detected in their blood. It is intended for home use by persons with little or no experience in obtaining blood spot samples for medical testing. The kit contains all components necessary to collect and send your blood spot sample to a qualified laboratory for testing.
Home Access Health Corporation
20
In Commercial Distribution

  • M769HIVEXPRESS201 ()


  • Capillary blood collection set, home-use
Alpha-Stim Conducting Solution 250 ml
Electromedical Products International, Inc.
SL250
In Commercial Distribution

  • 00857869005284 ()
  • 00857869005291 ()


  • Electrode conductive medium
Alpha-Stim Conducting Solution 50 ml
Electromedical Products International, Inc.
SL50
In Commercial Distribution

  • 00857869005277 ()
  • 10857869005274 ()


  • Electrode conductive medium
STENT PRB35-08-060-120 PROTEGE EF V09
Covidien LP
PRB35-08-060-120
Not in Commercial Distribution

  • 00821684069028 ()

  • Catheter Gauge: 6.0 French
  • Length: 60.0 Millimeter


  • Peripheral artery stent, bare-metal
STENT PRB35-07-060-120 PROTEGE EF V09
Covidien LP
PRB35-07-060-120
Not in Commercial Distribution

  • 00821684068861 ()

  • Catheter Gauge: 6.0 French
  • Length: 60.0 Millimeter


  • Peripheral artery stent, bare-metal
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