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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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Blood Irradiator
Best Theratronics Ltd
1000
In Commercial Distribution

  • 07540146000012 ()


  • In vitro ionizing-radiation blood irradiator
The exsalt™ PT7 Contact Layer (PT7) is indicated for use on partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second-degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and graft wounds. The exsalt™ PT7 Contact Layer maintains its antibacterial activity for up to seven days as shown in vitro against Staphylococcus aureus, Escherichia coli, Enterococcus faecalis, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter baumannii. Silver in the exsalt™ PT7 Contact Layer inhibits bacterial growth in the dressing.
Exciton Technologies Inc
PN-09-0066
In Commercial Distribution

  • 07540127000505 ()
  • 07540127000499 ()
  • 07540127000512 ()

  • Area/Surface Area: 512 Square inch
CL1632

  • Wound-nonadherent dressing, absorbent, antimicrobial
antimicrobial wound dressing, 4" x 66" in size
Exciton Technologies Inc
BM-09-0166
In Commercial Distribution

  • 07540127000468 ()
  • 07540127000475 ()
  • 07540127000482 ()
T70466

  • Wound-nonadherent dressing, absorbent, antimicrobial
The exsalt™ PT7 Contact Layer (PT7) is indicated for use on partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second-degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and graft wounds. The exsalt™ PT7 Contact Layer maintains its antibacterial activity for up to seven days as shown in vitro against Staphylococcus aureus, Escherichia coli, Enterococcus faecalis, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter baumannii. Silver in the exsalt™ PT7 Contact Layer inhibits bacterial growth in the dressing.
Exciton Technologies Inc
PN-09-0065
In Commercial Distribution

  • 07540127000444 ()
  • 07540127000437 ()
  • 07540127000451 ()

  • Area/Surface Area: 256 Square inch
CL1616

  • Wound-nonadherent dressing, absorbent, antimicrobial
The exsalt™ PT7 Contact Layer (PT7) is indicated for use on partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second-degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and graft wounds. The exsalt™ PT7 Contact Layer maintains its antibacterial activity for up to seven days as shown in vitro against Staphylococcus aureus, Escherichia coli, Enterococcus faecalis, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter baumannii. Silver in the exsalt™ PT7 Contact Layer inhibits bacterial growth in the dressing.
Exciton Technologies Inc
PN-09-0064
In Commercial Distribution

  • 07540127000413 ()
  • 07540127000406 ()
  • 07540127000420 ()

  • Area/Surface Area: 128 Square inch
CL0816

  • Wound-nonadherent dressing, absorbent, antimicrobial
The exsalt™ PT7 Contact Layer (PT7) is indicated for use on partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second-degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and graft wounds. The exsalt™ PT7 Contact Layer maintains its antibacterial activity for up to seven days as shown in vitro against Staphylococcus aureus, Escherichia coli, Enterococcus faecalis, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter baumannii. Silver in the exsalt™ PT7 Contact Layer inhibits bacterial growth in the dressing.
Exciton Technologies Inc
PN-09-0063
In Commercial Distribution

  • 07540127000383 ()
  • 07540127000376 ()
  • 07540127000390 ()

  • Area/Surface Area: 36 Square inch
CL0606

  • Wound-nonadherent dressing, absorbent, antimicrobial
The exsalt™ PT7 Contact Layer (PT7) is indicated for use on partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second-degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and graft wounds. The exsalt™ PT7 Contact Layer maintains its antibacterial activity for up to seven days as shown in vitro against Staphylococcus aureus, Escherichia coli, Enterococcus faecalis, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter baumannii. Silver in the exsalt™ PT7 Contact Layer inhibits bacterial growth in the dressing.
Exciton Technologies Inc
PN-09-0062
In Commercial Distribution

  • 07540127000352 ()
  • 07540127000345 ()
  • 07540127000369 ()

  • Area/Surface Area: 20 Square inch
CL0405

  • Wound-nonadherent dressing, absorbent, antimicrobial
1 Bone-Lok PLS Implant
INTERVENTIONAL SPINE, INC
9045-01
Not in Commercial Distribution

  • 81195401000324 ()
9045-01

  • Bone-screw internal spinal fixation system, sterile
No Description
INNO HEALTH TECHNOLOGY CO., LTD.
IDOC-01 Vitall
In Commercial Distribution

  • 74719874910005 ()
  • 04719874910006 ()


  • Acupuncture unit, home-use
V. Mueller NEURO PATTIES X-RAY DETECTABLE 3 X 3IN 76 X 76MM
STERIS CORPORATION
23275-580
Not in Commercial Distribution

  • 70885403302895 ()
  • 10885403302893 ()
  • 50885403302891 ()
23275580

  • Neurosurgical sponge
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