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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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Cytocell Aquarius - 05055844901605

P53 (TP53) Deletion FISH Probe Kit
CYTOCELL LIMITED
USA-LPH017
In Commercial Distribution

  • 05055844901605 ()
USA-LPH017

  • Myelodysplastic syndrome (MDS) IVD, probe
  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe

Cytocell Aquarius - 05055844901582

EVI1 (MECOM) Breakapart FISH Probe Kit
CYTOCELL LIMITED
USA-LPH036
In Commercial Distribution

  • 05055844901582 ()
USA-LPH036

  • Myelodysplastic syndrome (MDS) IVD, probe
  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe

Cytocell Aquarius - 05055844901551

Del(5q) Deletion FISH Probe Kit
CYTOCELL LIMITED
USA-LPH024
In Commercial Distribution

  • 05055844901551 ()
USA-LPH024

  • Myelodysplastic syndrome (MDS) IVD, probe
  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe

CytoCell - 05055844923904

EVI1 (MECOM) Breakapart FISH Probe Kit (IVD (USA))
CYTOCELL LIMITED
USA-LPH036
In Commercial Distribution



  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe
  • Myelodysplastic syndrome (MDS) IVD, probe

CytoCell - 05055844923881

Del(7q) Deletion FISH Probe Kit (IVD (USA))
CYTOCELL LIMITED
USA-LPH025
In Commercial Distribution



  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe
  • Myelodysplastic syndrome (MDS) IVD, probe

CytoCell - 05055844923874

Del(5q) Deletion FISH Probe Kit (IVD (USA))
CYTOCELL LIMITED
USA-LPH024
In Commercial Distribution



  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe
  • Myelodysplastic syndrome (MDS) IVD, probe

CytoCell - 05055844923843

P53 (TP53) Deletion FISH Probe Kit (IVD (USA))
CYTOCELL LIMITED
USA-LPH017
In Commercial Distribution



  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe
  • Myelodysplastic syndrome (MDS) IVD, probe

CytoCell - 05055844923836

MLL (KMT2A) Breakapart FISH Probe Kit (IVD (USA))
CYTOCELL LIMITED
USA-LPH013
In Commercial Distribution



  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe
  • Myelodysplastic syndrome (MDS) IVD, probe

Arthrex Calcium Sulfate BioBeads, 20 cc - 00850018568180

BONE VOID FILLER
DIMENSIONAL BIOCERAMICS LLC
ABS-3000-20
In Commercial Distribution

  • 00850018568180 ()

  • Total Volume: 20 Milliliter
ABS-3000-20

  • Bone matrix implant, synthetic, non-antimicrobial

Acrylic Spheres 20 mm, 3.6 cc - 10697660000357

Acrylic spheres are permanent implants used to replace the lost volume and to give motility to the ocular prosthesis following an enucleation, evisceration or an insertion of a secondary implant (to replace an implant that was or has to be removed) in ophthalmology. These ocular implants are sold non sterile. They must be sterilized before usage. The users must gas sterilize (EtO) the acrylic spheres (not autoclave). The ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-320
Not in Commercial Distribution


  • Outer Diameter: 20 Millimeter
  • Total Volume: 3.6 Milliliter


  • Orbital sphere implant
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