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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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Q Pedicle Instruments - 10888857553057

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

  • 10888857553057 ()
48111001

  • Scalpel handle, 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 - 10888857552937

Q Drill - Large Ø5.0mm
K2M, INC.
48111150
In Commercial Distribution

  • 10888857552937 ()
48111150

  • Fluted surgical drill bit, reusable

Q Pedicle Instruments - 10888857552913

Q Drill - Large Ø7.5mm
K2M, INC.
48111175
In Commercial Distribution

  • 10888857552913 ()
48111175

  • 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

Q Pedicle Instruments - 10888857552562

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

  • 10888857552562 ()
48112630

  • Bone tap, reusable

Q Pedicle Instruments - 10888857552548

Serrato Q Tap Ø4.0mm
K2M, INC.
48112640
In Commercial Distribution

  • 10888857552548 ()
48112640

  • Bone tap, reusable

Q Pedicle Instruments - 10888857552524

Serrato Q Tap Ø5.0mm
K2M, INC.
48112650
In Commercial Distribution

  • 10888857552524 ()
48112650

  • Bone tap, reusable

Q Pedicle Instruments - 10888857552494

Serrato Q Tap Ø7.5mm
K2M, INC.
48112675
In Commercial Distribution

  • 10888857552494 ()
48112675

  • Bone tap, reusable

Q Pedicle Instruments - 10888857552487

Serrato Q Tap Ø8.5mm
K2M, INC.
48112685
In Commercial Distribution

  • 10888857552487 ()
48112685

  • Bone tap, reusable

Q Pedicle Instruments - 10888857552470

Serrato Q Tap Ø9.5mm
K2M, INC.
48112695
In Commercial Distribution

  • 10888857552470 ()
48112695

  • Bone tap, reusable

Q Pedicle Instruments - 10888857552319

Q Ratchet Screwdriver Quick-Connect
K2M, INC.
48113402
In Commercial Distribution

  • 10888857552319 ()
48113402

  • Surgical screwdriver, reusable

Q Pedicle Instruments - 10888857552203

Q Small Tissue Sleeve
K2M, INC.
48131000
In Commercial Distribution

  • 10888857552203 ()
48131000

  • Surgical instrument guard, reusable

Q Pedicle Instruments - 10888857552173

Q S2AI Drill Ø7.5mm
K2M, INC.
48131785
In Commercial Distribution

  • 10888857552173 ()
48131785

  • Fluted surgical drill bit, reusable

ACS - 00191072198037

SUB Q RECORDER PACK
AMERICAN CONTRACT SYSTEMS, INC.
BPRC87B
In Commercial Distribution

  • 00191072198037 ()


  • General surgical procedure kit, non-medicated, single-use

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

CARDINAL HEALTH - 10888439173734

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

  • 50888439173732 ()
  • 10888439173734 ()
SBAHFSQBMA

  • General surgical procedure kit, medicated

ACS - 00191072001177

SUB Q RECORDER PACK
AMERICAN CONTRACT SYSTEMS, INC.
BHCP67D
In Commercial Distribution

  • 00191072001177 ()


  • General surgical procedure kit, non-medicated, single-use

Marina Medical - 00840306824586

POP Q Exam Stick
MARINA MEDICAL INSTRUMENTS, INC.
222-222A
In Commercial Distribution

  • 00840306824586 ()
222-222A

  • Ophthalmic surgical instrument handle, manual

Arjo Wiggins Medical, Inc. - 00815588021169

44 9.5X10 1000_CASE Q
STERIMED INC.
1010449.510
In Commercial Distribution

  • 00815588021169 ()
  • 00815588021152 ()
1010449.510

  • Sterilization packaging, single-use

Arjo Wiggins Medical, Inc. - 00815588021084

44 10X10 1000_CASE Q
STERIMED INC.
1010441010
In Commercial Distribution

  • 00815588021084 ()
  • 00815588021022 ()
1010441010

  • Sterilization packaging, single-use

CARDINAL HEALTH - 10195594912710

SUB Q RECORDER PACK
Cardinal Health 200, LLC
SBAHFSQBM3
In Commercial Distribution

  • 50195594912718 ()
  • 10195594912710 ()
SBAHFSQBM3

  • General surgical procedure kit, medicated

CARDINAL HEALTH - 10195594634582

SUB Q RECORDER PACK
Cardinal Health 200, LLC
SBAHFSQBM4
In Commercial Distribution

  • 50195594634580 ()
  • 10195594634582 ()
SBAHFSQBM4

  • General surgical procedure kit, medicated

CytoCell - 05055844905979

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

CytoCell - 05055844905962

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

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

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 - 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
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