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

USA-LPH017

  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe
  • Myelodysplastic syndrome (MDS) IVD, probe
MLL (KMT2A) Breakapart FISH Probe Kit
CYTOCELL LIMITED
USA-LPH013
In Commercial Distribution

USA-LPH013

  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe
  • Myelodysplastic syndrome (MDS) IVD, probe
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
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
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
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
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
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
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
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
EYE Q STERILE LABELS
CENTURION MEDICAL PRODUCTS CORPORATION
STL3024
In Commercial Distribution

  • 10653160230205 ()
  • 00653160230208 ()
STL3024

  • Procedural medication labelling set
Q Screwdriver Guide Tube
K2M, INC.
48110000
In Commercial Distribution

  • 10888857553217 ()
48110000

  • Surgical screwdriver, reusable
Q Signature Instruments Tray
K2M, INC.
48110005
In Commercial Distribution

  • 10888857553163 ()
48110005

  • Instrument tray, reusable
Q Pelvic Post Screwdriver
K2M, INC.
48110016
In Commercial Distribution

  • 10888857553101 ()
48110016

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Q Ratchet Round Handle
K2M, INC.
48111000
In Commercial Distribution

  • 10888857553064 ()
48111000

  • Surgical instrument handle, non-torque-limiting
Q Gear Shift Handle
K2M, INC.
48111002
In Commercial Distribution

  • 10888857553040 ()
48111002

  • Surgical instrument handle, non-torque-limiting
Everest Q Tap Ø10.5mm
K2M, INC.
48112415
In Commercial Distribution

  • 10888857552739 ()
48112415

  • Bone tap, reusable
Everest Q Tap Ø3.5mm
K2M, INC.
48112435
In Commercial Distribution

  • 10888857552722 ()
48112435

  • Bone tap, reusable
Everest Q Tap Ø5.5mm
K2M, INC.
48112455
In Commercial Distribution

  • 10888857552708 ()
48112455

  • Bone tap, reusable
Everest Q Tap Ø7.5mm
K2M, INC.
48112475
In Commercial Distribution

  • 10888857552685 ()
48112475

  • Bone tap, reusable
Everest Q Tap Ø9.5mm
K2M, INC.
48112495
In Commercial Distribution

  • 10888857552661 ()
48112495

  • Bone tap, reusable
Serrato Q Tap Ø4.0mm
K2M, INC.
48112640
In Commercial Distribution

  • 10888857552548 ()
48112640

  • Bone tap, reusable
Serrato Q Tap Ø5.0mm
K2M, INC.
48112650
In Commercial Distribution

  • 10888857552524 ()
48112650

  • Bone tap, reusable
Serrato Q Tap Ø5.5mm
K2M, INC.
48112655
In Commercial Distribution

  • 10888857552517 ()
48112655

  • Bone tap, reusable
Serrato Q Tap Ø6.5mm
K2M, INC.
48112665
In Commercial Distribution

  • 10888857552500 ()
48112665

  • Bone tap, reusable
Serrato Q Tap Ø7.5mm
K2M, INC.
48112675
In Commercial Distribution

  • 10888857552494 ()
48112675

  • Bone tap, reusable
Serrato Q Tap Ø8.5mm
K2M, INC.
48112685
In Commercial Distribution

  • 10888857552487 ()
48112685

  • Bone tap, reusable
Serrato Q Tap Ø9.5mm
K2M, INC.
48112695
In Commercial Distribution

  • 10888857552470 ()
48112695

  • Bone tap, reusable
Q Guided Elite Sleeve
K2M, INC.
48115400
In Commercial Distribution

  • 10888857552210 ()
48115400

  • Surgical drill guide, reusable
Q S2AI Drill Ø5.0mm
K2M, INC.
48131585
In Commercial Distribution

  • 10888857552197 ()
48131585

  • Fluted surgical drill bit, reusable
Q S2AI Drill Ø7.5mm
K2M, INC.
48131785
In Commercial Distribution

  • 10888857552173 ()
48131785

  • Fluted surgical drill bit, reusable
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
SUB Q RECORDER PACK
Cardinal Health 200, LLC
SBAHFSQBMA
In Commercial Distribution

  • 50888439173732 ()
  • 10888439173734 ()
SBAHFSQBMA

  • General surgical procedure kit, medicated
SUB Q RECORDER PACK
Cardinal Health 200, LLC
SBAHFSQBMB
In Commercial Distribution

  • 50888439239032 ()
  • 10888439239034 ()
SBAHFSQBMB

  • General surgical procedure kit, medicated
SUB Q RECORDER PACK
Cardinal Health 200, LLC
SBAHFSQBM2
In Commercial Distribution

  • 50888439403587 ()
  • 10888439403589 ()
SBAHFSQBM2

  • General surgical procedure kit, medicated
SUB Q RECORDER PACK
Cardinal Health 200, LLC
SBAHFSQBM1
In Commercial Distribution

  • 50888439317549 ()
  • 10888439317541 ()
SBAHFSQBM1

  • General surgical procedure kit, medicated
Q Screwdriver Spin Sleeve
K2M, INC.
48140020
In Commercial Distribution

  • 10888857553224 ()
48140020

  • Surgical screwdriver, reusable
Q Robotics Instruments Tray
K2M, INC.
48110002
In Commercial Distribution

  • 10888857553194 ()
48110002

  • Instrument tray, reusable
Q Pelvic Mount Tightener
K2M, INC.
48110015
In Commercial Distribution

  • 10888857553118 ()
48110015

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Q Guided Incision Tool
K2M, INC.
48111001
In Commercial Distribution

  • 10888857553057 ()
48111001

  • Scalpel handle, reusable
Q Drill - Small Ø2.5mm
K2M, INC.
48111025
In Commercial Distribution

  • 10888857552999 ()
48111025

  • Fluted surgical drill bit, reusable
Q Drill - Small Ø3.5mm
K2M, INC.
48111035
In Commercial Distribution

  • 10888857552982 ()
48111035

  • Fluted surgical drill bit, reusable
Q Drill - Small Ø4.0mm
K2M, INC.
48111040
In Commercial Distribution

  • 10888857552975 ()
48111040

  • Fluted surgical drill bit, reusable
Q Drill - Small Ø4.5mm
K2M, INC.
48111045
In Commercial Distribution

  • 10888857552968 ()
48111045

  • Fluted surgical drill bit, reusable
Q Drill - Small Ø5.0mm
K2M, INC.
48111050
In Commercial Distribution

  • 10888857552951 ()
48111050

  • Fluted surgical drill bit, reusable
Q Drill - Large Ø5.0mm
K2M, INC.
48111150
In Commercial Distribution

  • 10888857552937 ()
48111150

  • Fluted surgical drill bit, reusable
Q Drill - Large Ø6.5mm
K2M, INC.
48111165
In Commercial Distribution

  • 10888857552920 ()
48111165

  • Fluted surgical drill bit, reusable
Q Drill - Large Ø7.5mm
K2M, INC.
48111175
In Commercial Distribution

  • 10888857552913 ()
48111175

  • Fluted surgical drill bit, reusable
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