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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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Dandy Scan body, by CoreMedTech, for dental Intraoral scanning. This product is made of Titanium for durability with a light-dispersing surface to maximize scanning efficacy.
Coremedtech ApS
BEB, ZimVie - External Ø3.75
In Commercial Distribution

  • 05744003810055 ()
80610174

  • Dental implant abutment analog, intraoral-scanning, single-use
Dandy Scan body, by CoreMedTech, for dental Intraoral scanning. This product is made of Titanium for durability with a light-dispersing surface to maximize scanning efficacy.
Coremedtech ApS
BEP, ZimVie - External Ø3.25
In Commercial Distribution

  • 05744003810048 ()
80610173

  • Dental implant abutment analog, intraoral-scanning, single-use
Dandy Scan body, by CoreMedTech, for dental Intraoral scanning. This product is made of Titanium for durability with a light-dispersing surface to maximize scanning efficacy.
Coremedtech ApS
BCG, ZimVie - Certain Ø6.0
In Commercial Distribution

  • 05744003810031 ()
80610169

  • Dental implant abutment analog, intraoral-scanning, single-use
Dandy Scan body, by CoreMedTech, for dental Intraoral scanning. This product is made of Titanium for durability with a light-dispersing surface to maximize scanning efficacy.
Coremedtech ApS
BCY, ZimVie - Certain Ø5.0
In Commercial Distribution

  • 05744003810024 ()
80610168

  • Dental implant abutment analog, intraoral-scanning, single-use
Dandy Scan body, by CoreMedTech, for dental Intraoral scanning. This product is made of Titanium for durability with a light-dispersing surface to maximize scanning efficacy.
Coremedtech ApS
BCB, ZimVie - Certain Ø4.1
In Commercial Distribution

  • 05744003810017 ()
80610167

  • Dental implant abutment analog, intraoral-scanning, single-use
Dandy Scan body, by CoreMedTech, for dental Intraoral scanning. This product is made of Titanium for durability with a light-dispersing surface to maximize scanning efficacy.
Coremedtech ApS
BCP, ZimVie - Certain Ø3.4
In Commercial Distribution

  • 05744003810000 ()
80610166

  • Dental implant abutment analog, intraoral-scanning, single-use
The Cambridge Biotech HIV-1 Urine Western Blot Kit is an in vitro qualitative assay for the detection and identification of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in urine specimens. This more specific assay is used as a supplemental test with urine specimens that tested repeatedly reactive using a screening procedure (Urine EIA Kit). The test is intended for use in professional laboratory settings as an aid in clinical diagnosis of HIV infection.
BLUEJAY DIAGNOSTICS, INC.
01
In Commercial Distribution

  • 00864525000422 ()
  • 00450000000027 ()
45000

  • HIV1 antibody IVD, kit, immunoblot
The Maxim HIV-1 Urine Enzyme Immunoassay is an enzyme immunoassay for the in vitro detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in urine. The test is intended for use in professional laboratory settings as an aid in clinical diagnosis of HIV infection. Before a determination of HIV-1 status can be made, specimens that are repeatedly reactive using this test should be further tested only using the additional, more specific, Cambridge Biotech HIV-1 Urine Western Blot test.
BLUEJAY DIAGNOSTICS, INC.
01
In Commercial Distribution

  • 00864525000415 ()
40000

  • HIV1 antibody IVD, kit, enzyme immunoassay (EIA)
Allereye® is a rapid immunoassay for the detection of total IgE in tears.
BLUEJAY DIAGNOSTICS, INC.
01
In Commercial Distribution

  • 00864525000408 ()
380003G

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
Pulsed Electromagnetic Field (pEMF) generator for use with NeuroField Software Suite. Stimulation unit for low-intensity neurofeedback.
NEUROFIELD, INC.
17
In Commercial Distribution

  • 00860410000300 ()


  • Kinesiology/electromyographic sensor set
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