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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ALIMED, INC.
65961
In Commercial Distribution

  • 00733657217421 ()
2970005851

  • Abdominal binder, reusable
Optional Bariatric Pivoting Calf Panel Assembly for use with the LNX Power Center Mount Legrest (upper assy) or the Compact Power Down LNX CM Legrest. Includes mounting hardware. Padded Calf Panel sold separately. Optional wheelchair component designed for use with Motion Concepts power positioning systems.
Motion Concepts Inc
D-0101-LNXPCP
In Commercial Distribution

  • 07540147002886 ()
LNXPCP

  • Wheelchair footrest/legrest
WORKSURFACE, REAR BENEATH COUNTER W/DUO UNIT LEFT/RIGHT & VERTICAL REMOTE MOUNT PANEL CONTROL
Ls Enterprises, Inc.
2184BC
In Commercial Distribution

  • D0692184BC0 ()


  • Dental delivery system
Lyphochek Allergen sIgE Control Panel A MiniPak (An assayed human serum allergen sIgE control.)
BIO-RAD LABORATORIES, INC.
12000144
In Commercial Distribution

  • 00847661005759 ()
12000144

  • Multiple allergen-specific immunoglobulin E (IgE) antibody IVD, control
The E-Series Spindle Hybrid Dual Flat Panel Monitor is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995171155 ()
LES000019

  • Medical monitor/light mount
The HarmonyAIR E-Series Spindle Single Flat Panel Monitor is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995171056 ()
LES000007

  • Medical monitor/light mount
QC Sets and Panels: Helix Elite™ Carbapenem-resistant Enterobacteriaceae (CRE) Control Panel (Inactivated Swab)
MICROBIOLOGICS INC.
8187
In Commercial Distribution

  • 70845357041172 ()
8187

  • Multiple bacteria carbapenemase nucleic acid IVD, control
QC Sets and Panels: KWIK-STIK™ Blood Culture Identification (BCID) Verification Panel (Live Culture)
MICROBIOLOGICS INC.
5229P
Not in Commercial Distribution

  • 70845357038899 ()
5229P

  • Multiple bacteria species culture isolate identification control IVD, kit
QC Sets and Panels: Helix Elite™ Flu A/Flu B/SARS-CoV-2 Control Panel
MICROBIOLOGICS INC.
CL00016
In Commercial Distribution

  • 80845357044415 ()
CL00016

  • Multiple-genus respiratory virus nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Flu/RSV/SARS-CoV-2 Control Panel Sample Kit
MICROBIOLOGICS INC.
8246-SPL
In Commercial Distribution

  • 70845357044388 ()
8246-SPL

  • Multiple-genus respiratory virus nucleic acid IVD, control
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