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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 - 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

CARDINAL HEALTH - 10888439317541

SUB Q RECORDER PACK
Cardinal Health 200, LLC
SBAHFSQBM1
In Commercial Distribution

  • 50888439317549 ()
  • 10888439317541 ()
SBAHFSQBM1

  • General surgical procedure kit, medicated

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

CARDINAL HEALTH - 10888439173734

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

  • 50888439173732 ()
  • 10888439173734 ()
SBAHFSQBMA

  • General surgical procedure kit, medicated

Q Pedicle Instruments - 10888857553224

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

  • 10888857553224 ()
48140020

  • Surgical screwdriver, reusable

Q Pedicle Instruments - 10888857553217

Q Screwdriver Guide Tube
K2M, INC.
48110000
In Commercial Distribution

  • 10888857553217 ()
48110000

  • Surgical screwdriver, reusable

Q Pedicle Instruments - 10888857553194

Q Robotics Instruments Tray
K2M, INC.
48110002
In Commercial Distribution

  • 10888857553194 ()
48110002

  • Instrument tray, reusable

Q Pedicle Instruments - 10888857553163

Q Signature Instruments Tray
K2M, INC.
48110005
In Commercial Distribution

  • 10888857553163 ()
48110005

  • Instrument tray, 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 - 10888857553101

Q Pelvic Post Screwdriver
K2M, INC.
48110016
In Commercial Distribution

  • 10888857553101 ()
48110016

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Q Pedicle Instruments - 10888857553064

Q Ratchet Round Handle
K2M, INC.
48111000
In Commercial Distribution

  • 10888857553064 ()
48111000

  • Surgical instrument handle, non-torque-limiting

Q Pedicle Instruments - 10888857553057

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

  • 10888857553057 ()
48111001

  • Scalpel handle, reusable

Q Pedicle Instruments - 10888857553040

Q Gear Shift Handle
K2M, INC.
48111002
In Commercial Distribution

  • 10888857553040 ()
48111002

  • Surgical instrument handle, non-torque-limiting

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 - 10888857552975

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

  • 10888857552975 ()
48111040

  • 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 - 10888857552951

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

  • 10888857552951 ()
48111050

  • Fluted surgical drill bit, reusable
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