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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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2 - 0.75mm x 0.50cm VISICOIL MR separated by a 15mm PGLA Spacer (Stranded with PGLA Sleeve) loaded in an 18 gauge pre-waxed brachytherapy needle 20cm in length.
Izi Medical Products, LLC
MRTLS-075-51518
In Commercial Distribution

  • EIBAMRTLS075515180 ()
MRTLS-075-51518

  • Radiological image marker, implantable
STELLAR DC Acrylic is a dual cure acrylic that light cures in 20 seconds and self cures in 120 seconds. Used for repairing and relining clear splints.
Taub Products
Splint Clear - Evaluator
In Commercial Distribution

  • D8375050800 ()

  • Weight: 5.85 Gram
50-5080

  • Dental acrylic resin
A light curing material to be used to create a custom impression tray intended for filling with dental impression materials. Used in dentistry and in the laboratory.
bisico Bielefelder Dentalsilicone GmbH & Co. KG
03250
In Commercial Distribution

  • EBIB032501 ()
03250

  • Dental impression tray material
The Accula™ Flu A / B Control Kit is intended for in vitro diagnostic use in quality control testing with the Accula™ Flu A / B Test.
MESA BIOTECH, INC.
FAB1100CW-C
In Commercial Distribution

  • B540FAB1100CWC0 ()
FAB1100CW-1

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
The Silaris™ Influenza A&B Control Kit is intended for in vitro diagnostic use in quality control testing with the Silaris™ Influenza A&B Test.
MESA BIOTECH, INC.
1024
In Commercial Distribution

  • B54010240 ()
1024

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
Content: 20 ml For colouring fissures in the occlusal area (in-depth effect) or interdental area It is also suitable for darker teeth in the cervical area Colour Liquid for Prettau® Zirconia for brush technique Use only in combination with metal-free brushes
ZIRKONZAHN SRL
FMAA5403
In Commercial Distribution

  • D800FMAA5403 ()


  • Dental articulation paste/solution
Content: 20 ml For colouring fissures in the occlusal area (in-depth effect) or interdental area It is also suitable for darker teeth in the cervical area Colour Liquid for Prettau® Zirconia for brush technique Use only in combination with metal-free brushes
ZIRKONZAHN SRL
FMAA5303
In Commercial Distribution

  • D800FMAA5303 ()


  • Dental articulation paste/solution
No Description
BTL INDUSTRIES LIMITED
BTL-703
In Commercial Distribution

  • B108703POENUS0100 ()


  • Multi-modality hyperthermia system
PolyDetector ALK Scarlet Substrate-Chromogen used in Alkaline Phosphatase Detection Systems for the demonstration of cell antigens or nucleic acids in paraffin-embedded tissues, cryostat sections, cytosmears, and cell preparations.
BIO SB, INC.
1000 ml
In Commercial Distribution

  • B502BSB01420 ()
BSB 0142

  • Chromogenic/colorimetric substrate reagent IVD
PolyDetector ALK Scarlet Substrate-Chromogen used in Alkaline Phosphatase Detection Systems for the demonstration of cell antigens or nucleic acids in paraffin-embedded tissues, cryostat sections, cytosmears, and cell preparations.
BIO SB, INC.
200 ml
In Commercial Distribution

  • B502BSB01410 ()
BSB 0141

  • Chromogenic/colorimetric substrate reagent IVD
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