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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 - 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

Centurion - 00653160230208

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

  • 10653160230205 ()
  • 00653160230208 ()
STL3024

  • Procedural medication labelling set

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 - 10888439239034

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

  • 50888439239032 ()
  • 10888439239034 ()
SBAHFSQBMB

  • General surgical procedure kit, medicated

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 - 10888857552982

Q Drill - Small Ø3.5mm
K2M, INC.
48111035
In Commercial Distribution

  • 10888857552982 ()
48111035

  • Fluted surgical drill bit, reusable

Q Pedicle Instruments - 10888857552968

Q Drill - Small Ø4.5mm
K2M, INC.
48111045
In Commercial Distribution

  • 10888857552968 ()
48111045

  • Fluted surgical drill bit, reusable

Q Pedicle Instruments - 10888857552920

Q Drill - Large Ø6.5mm
K2M, INC.
48111165
In Commercial Distribution

  • 10888857552920 ()
48111165

  • Fluted surgical drill bit, reusable

Q Pedicle Instruments - 10888857552906

Q Small Guide Tube
K2M, INC.
48111400
In Commercial Distribution

  • 10888857552906 ()
48111400

  • Surgical drill guide, 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

Q Pedicle Instruments - 10888857552661

Everest Q Tap Ø9.5mm
K2M, INC.
48112495
In Commercial Distribution

  • 10888857552661 ()
48112495

  • Bone tap, reusable

Q Pedicle Instruments - 10888857552579

Serrato Q Tap Ø10.5mm
K2M, INC.
48112615
In Commercial Distribution

  • 10888857552579 ()
48112615

  • Bone tap, reusable

Q Pedicle Instruments - 10888857552562

Serrato Q Tap Ø3.0mm
K2M, INC.
48112630
In Commercial Distribution

  • 10888857552562 ()
48112630

  • Bone tap, reusable
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