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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 - 05055844901599

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

  • 05055844901599 ()
USA-LPH013

  • 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 - 05055844901568

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

  • 05055844901568 ()
USA-LPH025

  • 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 - 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 - 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 - 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

CytoCell - 05055844905955

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

USA-LPH036

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

CytoCell - 05055844905931

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

USA-LPH025

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

CytoCell - 05055844905924

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

USA-LPH024

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

Centurion - 00653160230208

EYE Q STERILE LABELS
CENTURION MEDICAL PRODUCTS CORPORATION
STL3024
In Commercial Distribution

  • 10653160230205 ()
  • 00653160230208 ()
STL3024

  • Procedural medication labelling set

CARDINAL HEALTH - 10888439173734

SUB Q RECORDER PACK
Cardinal Health 200, LLC
SBAHFSQBMA
In Commercial Distribution

  • 50888439173732 ()
  • 10888439173734 ()
SBAHFSQBMA

  • General surgical procedure kit, medicated

Zimmer® Cannulated Screw System - 00846468074173

Q/C CANNULATED T-HANDLE
Pioneer Surgical Technology, Inc.
00-1147-050-00
In Commercial Distribution

  • 00846468074173 ()
00-1147-050-00

  • Surgical instrument handle, non-torque-limiting

CARDINAL HEALTH - 10888439403589

SUB Q RECORDER PACK
Cardinal Health 200, LLC
SBAHFSQBM2
In Commercial Distribution

  • 50888439403587 ()
  • 10888439403589 ()
SBAHFSQBM2

  • General surgical procedure kit, medicated

CARDINAL HEALTH - 10888439239034

SUB Q RECORDER PACK
Cardinal Health 200, LLC
SBAHFSQBMB
In Commercial Distribution

  • 50888439239032 ()
  • 10888439239034 ()
SBAHFSQBMB

  • General surgical procedure kit, medicated

Quantum - D8255120000000

Q Fit Retention Coping
QUANTUM BIOENGINEERING LTD.
512-000-000
In Commercial Distribution

  • D8255120000000 ()

  • Outer Diameter: 3 Millimeter
  • Length: 5 Millimeter
512-000-000

  • Dental implant suprastructure, permanent, preformed

Q Pedicle Instruments - 10888857553224

Q Screwdriver Spin Sleeve
K2M, INC.
48140020
In Commercial Distribution

  • 10888857553224 ()
48140020

  • Surgical screwdriver, reusable

Q Pedicle Instruments - 10888857553118

Q Pelvic Mount Tightener
K2M, INC.
48110015
In Commercial Distribution

  • 10888857553118 ()
48110015

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Q Pedicle Instruments - 10888857553057

Q Guided Incision Tool
K2M, INC.
48111001
In Commercial Distribution

  • 10888857553057 ()
48111001

  • Scalpel handle, reusable

Q Pedicle Instruments - 10888857552999

Q Drill - Small Ø2.5mm
K2M, INC.
48111025
In Commercial Distribution

  • 10888857552999 ()
48111025

  • Fluted surgical drill bit, reusable

Q Pedicle Instruments - 10888857552975

Q Drill - Small Ø4.0mm
K2M, INC.
48111040
In Commercial Distribution

  • 10888857552975 ()
48111040

  • Fluted surgical drill bit, reusable

Q Pedicle Instruments - 10888857552951

Q Drill - Small Ø5.0mm
K2M, INC.
48111050
In Commercial Distribution

  • 10888857552951 ()
48111050

  • Fluted surgical drill bit, reusable

Q Pedicle Instruments - 10888857552876

Q Large Guide Tube
K2M, INC.
48111900
In Commercial Distribution

  • 10888857552876 ()
48111900

  • Surgical drill guide, reusable

Q Pedicle Instruments - 10888857552739

Everest Q Tap Ø10.5mm
K2M, INC.
48112415
In Commercial Distribution

  • 10888857552739 ()
48112415

  • Bone tap, reusable

Q Pedicle Instruments - 10888857552715

Everest Q Tap Ø4.5mm
K2M, INC.
48112445
In Commercial Distribution

  • 10888857552715 ()
48112445

  • Bone tap, reusable

Q Pedicle Instruments - 10888857552692

Everest Q Tap Ø6.5mm
K2M, INC.
48112465
In Commercial Distribution

  • 10888857552692 ()
48112465

  • Bone tap, reusable

Q Pedicle Instruments - 10888857552678

Everest Q Tap Ø8.5mm
K2M, INC.
48112485
In Commercial Distribution

  • 10888857552678 ()
48112485

  • Bone tap, reusable
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