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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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The Mohs Mouse/Rabbit PolyDetector HRP Brown Detection System is a 1-step Fab micropolymeric detection system that allows for the demonstration of antigens in cryostat sections, formalin-fixed paraffin-embedded tissue, and cell preparations.
BIO SB, INC.
BSB-0355-5
In Commercial Distribution

  • B502BSB035550 ()

  • Total Volume: 5 Milliliter
BSB-0355-5

  • Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry
The Mohs Mouse/Rabbit PolyDetector HRP Brown Detection System is a 1-step Fab micropolymeric detection system that allows for the demonstration of antigens in cryostat sections, formalin-fixed paraffin-embedded tissue, and cell preparations.
BIO SB, INC.
BSB 0307S
In Commercial Distribution

  • B502BSB0307S0 ()

  • Total Volume: 5 Milliliter
BSB 0307S

  • Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry
ETCH GEL 37% 5ML SYR BX4
BENCO DENTAL SUPPLY CO.
5186-498
In Commercial Distribution

  • D74451864980 ()

  • Total Volume: 5 Milliliter


  • Dental etching solution
Hahn Tapered Implant 5.0 x 16 mm
Prismatik Dentalcraft, Inc
70-1154-IMP0018
In Commercial Distribution

  • D745701154IMP00180 ()

  • Outer Diameter: 5 Millimeter
70-1154-IMP0018

  • Dental implant system
Hahn Tapered Implant 5.0 x 13 mm
Prismatik Dentalcraft, Inc
70-1154-IMP0017
In Commercial Distribution

  • D745701154IMP00170 ()

  • Outer Diameter: 5 Millimeter
70-1154-IMP0017

  • Dental implant system
Hahn Tapered Implant 5.0 x 11.5 mm
Prismatik Dentalcraft, Inc
70-1154-IMP0016
In Commercial Distribution

  • D745701154IMP00160 ()

  • Outer Diameter: 5 Millimeter
70-1154-IMP0016

  • Dental implant system
Hahn Tapered Implant 5.0 x 10 mm
Prismatik Dentalcraft, Inc
70-1154-IMP0015
In Commercial Distribution

  • D745701154IMP00150 ()

  • Outer Diameter: 5 Millimeter
70-1154-IMP0015

  • Dental implant system
Hahn Tapered Implant 5.0 x 8 mm
Prismatik Dentalcraft, Inc
70-1154-IMP0014
In Commercial Distribution

  • D745701154IMP00140 ()

  • Outer Diameter: 5 Millimeter
70-1154-IMP0014

  • Dental implant system
Universal Pulsing Set
Angiodynamics, Inc.
H787124017010
In Commercial Distribution


  • Catheter Gauge: 5 French
12401701

  • Peripheral vascular intervention infusion catheter
SIR-Y001 (3Gbq/5ml): SIR-Spheres Y90 resin microspheres consist of biocompatible resin microspheres containing yttrium-90 with a size between 20 and 60 microns in diameter. Each vial contains 3 GBq of Y90 ± 10% (at the time of calibration) in a total of 5 cc water for injection. Yttrium-90 is a high-energy pure beta-emitting isotope with no primary gamma emission. The maximum energy of the beta particles is 2.27MeV with a mean of 0.93MeV. The maximum range of emissions in tissue is 11mm with a mean of 2.5mm. This is a brachytherapy product considered to be a sealed source device. The yttrium-90 has a purity specification of 999,900 ppm at reference, at (or after) time of manufacture of SIR-Spheres microspheres. The half-life is 64.1 hours. In use requiring the isotope to decay to infinity, 94% of the radiation is delivered in 11 days leaving only background radiation with no therapeutic value. SIR-Spheres microspheres themselves are a permanent implant. Each device is for single patient use.
SIRTEX MEDICAL PTY LTD
SIR-Y001
Not in Commercial Distribution

  • M425SIRY0010 ()

  • Total Volume: 5 Milliliter


  • Manual brachytherapy source, permanent implant
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