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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D3 Ultra DFA Respiratory Virus ID Set
DIAGNOSTIC HYBRIDS, INC.
01-010007.V2
In Commercial Distribution

  • 30014613330356 ()
01-010007.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
D3 Ultra DFA Parainfluenza Reagent Set
DIAGNOSTIC HYBRIDS, INC.
01-010006.V2
In Commercial Distribution

  • 30014613330349 ()
01-010006.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
De Ultra DFA Influenza A/Influenza B Reagent Set
DIAGNOSTIC HYBRIDS, INC.
01-010004.V2
In Commercial Distribution

  • 30014613330325 ()
01-010004.V2

  • Influenza A/B virus antigen IVD, kit, fluorescent immunoassay
D3 Ultra DFA RSV Reagent Set
DIAGNOSTIC HYBRIDS, INC.
01-010003.V2
In Commercial Distribution

  • 30014613330318 ()
01-010003.V2

  • Respiratory syncytial virus (RSV) antigen IVD, kit, fluorescent immunoassay
D3 Ultra DFA Respiratory Virus Shell Vial Screening Set
DIAGNOSTIC HYBRIDS, INC.
01-010002.V2
In Commercial Distribution

  • 30014613330301 ()
01-010002.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
D3 Ultra DFA Respiratory Virus Direct Specimen Screening set
DIAGNOSTIC HYBRIDS, INC.
01-010001.V2
In Commercial Distribution

  • 30014613330295 ()
01-010001.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
D3 Ultra DFA Respiratory Virus Screening and ID kit
DIAGNOSTIC HYBRIDS, INC.
01-010000.V2
In Commercial Distribution

  • 30014613330288 ()
01-010000.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
ELVIS SOL 3, 12ML
DIAGNOSTIC HYBRIDS, INC.
00-013012.V2
In Commercial Distribution

  • 30014613330202 ()
00-013012.V2

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay
ELVIS SOL 3, 3ML
DIAGNOSTIC HYBRIDS, INC.
00-013003.V2
In Commercial Distribution

  • 30014613330196 ()
00-013003.V2

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay
* INACTIVE Software Upgrade, LiDCO LXI v2 for ICU Medical only (b1326)
LIDCO LIMITED
Li11057
Not in Commercial Distribution

  • 05060110522194 ()
Li11057

  • General-purpose multi-parameter bedside monitor
Loaner De Mayo V2®/V2E® Knee Positioner® Clamp
Innovative Medical Products, Inc
114-CL LOANER
In Commercial Distribution

  • 00696588006796 ()
114-CL LOANER

  • Medical table clamp
Evaluation De Mayo V2®/V2E® Knee Positioner® Clamp
Innovative Medical Products, Inc
114-CL EVAL
In Commercial Distribution

  • 00696588005393 ()
114-CL EVAL

  • Medical table clamp
Demo De Mayo V2®/V2E® Knee Positioner® Clamp
Innovative Medical Products, Inc
114-CL DEMO
In Commercial Distribution

  • 00696588005386 ()
114-CL DEMO

  • Medical table clamp
KINCISE MAKE TO ORDER V2 EMPHASYS STRAIGHT SHELL/LINER IMPACTOR LONG
DEPUY ORTHOPAEDICS, INC.
2999-66-993
In Commercial Distribution

  • 10603295552772 ()
299966993

  • Orthopaedic implant impactor, reusable
KINCISE MAKE TO ORDER V2 EMPHASYS STRAIGHT SHELL/LINER IMPACTOR SHORT
DEPUY ORTHOPAEDICS, INC.
2999-66-994
In Commercial Distribution

  • 10603295552758 ()
299966994

  • Orthopaedic implant impactor, reusable
Trade-In 800um SHP v2 Assy LightForce - less than 5 yrs old
DJO, LLC
PRD-000758-010-00-L-L5
In Commercial Distribution

  • 00190446897910 ()


  • Musculoskeletal/physical therapy laser beam guide, transcutaneous
Trade-In 800um SHP v2 Assy LightForce - more than 5 yrs old
DJO, LLC
PRD-000758-010-00-L-G5
In Commercial Distribution

  • 00190446897903 ()


  • Musculoskeletal/physical therapy laser beam guide, transcutaneous
Diagnostic Cardiology Leadwire, Dedicated Banana, AHA, 26 in / 66 cm, V2
Carefusion Finland 320 Oy
2020558-006
Not in Commercial Distribution

  • 10885403260308 ()
2020558-006

  • Electrocardiographic lead set, reusable
No Description
Biomet Uk Ltd
32-468456
In Commercial Distribution

  • 05019279496839 ()

  • 80MM
32-468456

  • Knee femur prosthesis trial, reusable
No Description
Biomet Uk Ltd
32-468451
In Commercial Distribution

  • 05019279496730 ()

  • 55mm
32-468451

  • Knee femur prosthesis trial, reusable
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