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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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Tinto Helicobacter pylori is a purified immunoglobulin fraction of rabbit antiserum that is filtered, sterilized and diluted in buffer pH 7.5, containing BSA and sodium azide as a preservative (analyte specific reagent)
BIO SB, INC.
BSB 5604 (ASR)
In Commercial Distribution

  • B502BSB5604ASR0 ()

  • Total Volume: 7 Milliliter
BSB 5604 (ASR)

  • Assay development analyte-specific reagent IVD
Tinto Helicobacter pylori is a purified immunoglobulin fraction of rabbit antiserum that is filtered, sterilized and diluted in buffer pH 7.5, containing BSA and sodium azide as a preservative (analyte specific reagent)
BIO SB, INC.
BSB 5603 (ASR)
In Commercial Distribution

  • B502BSB5603ASR0 ()

  • Total Volume: 3 Milliliter
BSB 5603 (ASR)

  • Assay development analyte-specific reagent IVD
Tinto Toxoplasma gondii is a purified immunoglobulin fraction of rabbit antiserum that is filtered, sterilized and diluted in buffer pH 7.5, containing BSA and sodium azide as a preservative (analyte specific reagent)
BIO SB, INC.
BSB 6045 (ASR)
In Commercial Distribution

  • B502BSB6045ASR0 ()

  • Total Volume: 15 Milliliter
BSB 6045 (ASR)

  • Assay development analyte-specific reagent IVD
Tinto Toxoplasma gondii is a purified immunoglobulin fraction of rabbit antiserum that is filtered, sterilized and diluted in buffer pH 7.5, containing BSA and sodium azide as a preservative (analyte specific reagent)
BIO SB, INC.
BSB 6044 (ASR)
In Commercial Distribution

  • B502BSB6044ASR0 ()

  • Total Volume: 7 Milliliter
BSB 6044 (ASR)

  • Assay development analyte-specific reagent IVD
Tinto Toxoplasma gondii is a purified immunoglobulin fraction of rabbit antiserum that is filtered, sterilized and diluted in buffer pH 7.5, containing BSA and sodium azide as a preservative (analyte specific reagent)
BIO SB, INC.
BSB 6043 (ASR)
In Commercial Distribution

  • B502BSB6043ASR0 ()

  • Total Volume: 3 Milliliter
BSB 6043 (ASR)

  • Assay development analyte-specific reagent IVD
The NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or skull bone fixation following craniotomy, cranioplasty, or craniectomy surgery. KTC 3-piece plate is made from PEEK.
Neurovention LLC
410-01
In Commercial Distribution

  • G28441001 ()


  • Cranioplasty plate, alterable
The NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or skull bone fixation following craniotomy, cranioplasty, or craniectomy surgery. KTC 2-piece plate is made from PEEK .
Neurovention LLC
409-01
In Commercial Distribution

  • G28440901 ()


  • Cranioplasty plate, alterable
Prolaryn Gel is a water-based injectable gel implant used in the vocal folds to treat vocal fold insuffiency. Prolaryn Gel resorbs within a period of 3-6 months and is a temporary implant.
MERZ NORTH AMERICA, INC.
8602M0K5
In Commercial Distribution

  • M2138602M0K55 ()

  • Total Volume: 1.0 Milliliter


  • Injectable vocal cord medialization implant, synthetic
Alpha-Dent® Alginate Impression Material is available in a variety of flavors and set types. This heavy body material is designed to produce consistent impressions. Each can includes powder scoop and vial.
DENTAL TECHNOLOGIES, INC.
604.0503.001
In Commercial Distribution

  • D73560405030010 ()
604.0503.001

  • Alginate dental impression material
Alpha-Dent® Alginate Impression Material is available in a variety of flavors and set types. This heavy body material is designed to produce consistent impressions. Each can includes powder scoop and vial.
DENTAL TECHNOLOGIES, INC.
604.0403.001
In Commercial Distribution

  • D73560404030010 ()
604.0403.001

  • Alginate dental impression material
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