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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Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 25mm
In Commercial Distribution

  • D960LVX00251 ()
30101107

  • Dental appliance fabrication material, ceramic
Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 24mm
In Commercial Distribution

  • D960LVX00241 ()
30101110

  • Dental appliance fabrication material, ceramic
Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 22mm
In Commercial Distribution

  • D960LVX00221 ()
30101106

  • Dental appliance fabrication material, ceramic
Powered walking assistance device
B-Temia Inc
5062601
In Commercial Distribution

  • 07540162060007 ()


  • Programmable ambulation exoskeleton, clinical
NxSTEP Unweighing System, 115VAC
BIODEX MEDICAL SYSTEMS, INC.
950-485
In Commercial Distribution

  • 00718175004852 ()
950-485

  • Mobile gait rehabilitation system, harness-support
NxSTEP Unweighing System, without Harness
BIODEX MEDICAL SYSTEMS, INC.
950-484
In Commercial Distribution

  • 00718175004845 ()
950-484

  • Mobile gait rehabilitation system, harness-support
NxSTEP Unweighing System
BIODEX MEDICAL SYSTEMS, INC.
945-480
In Commercial Distribution

  • 00718175004807 ()
945-480

  • Mobile gait rehabilitation system, harness-support
Mobility Assist
BIODEX MEDICAL SYSTEMS, INC.
950-570
In Commercial Distribution

  • 00718175005705 ()
950-570

  • Gait rehabilitation electronic walker
JBAIDS IVD Influenza A Subtyping Kit
BIOFIRE DEFENSE, LLC
JRPD-ASY-0138
Not in Commercial Distribution

  • 00851458005075 ()
JRPD-ASY-0138

  • Influenza A virus H5N1 subtype (avian influenza) nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0120
Not in Commercial Distribution

  • 00815381020147 ()
RFIT-ASY-0120

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
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