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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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Awl with Sleeve 2
Seaspine Orthopedics Corporation
92-0108
In Commercial Distribution

  • 10889981086602 ()
92-0108

  • Bone awl, reusable
14' with reflective luer
WESTMED, INC.
0915
Not in Commercial Distribution

  • 10709078005357 ()
  • 00709078005350 ()


  • Nasal oxygen cannula, carbon-dioxide-sampling
Screwdriver with A/O
Seaspine Orthopedics Corporation
SR-0282
In Commercial Distribution

  • 10889981161224 ()
SR-0282

  • Orthopaedic implant driver
Split Driver with Wings
Seaspine Orthopedics Corporation
SR-0263
In Commercial Distribution

  • 10889981160135 ()
SR-0263

  • Orthopaedic implant driver
Disc Wedge with Crossbar
Seaspine Orthopedics Corporation
SR-0267
In Commercial Distribution

  • 10889981159719 ()
SR-0267

  • Spinal implant trial
SHOULDER WITH POUCH PACK
Cardinal Health 200, LLC
SOPHDPSUBA
In Commercial Distribution

  • 50195594023940 ()
  • 10195594023942 ()
SOPHDPSUBA

  • Orthopaedic surgical procedure kit, medicated
Drainage System with Tee
TELEFLEX INCORPORATED
IPN913957
In Commercial Distribution

  • 24026704656916 ()
  • 14026704656919 ()
  • 04026704595488 ()
1740

  • Benchtop nebulizer, non-heated
OCULOPLASTIC PACK WITH PREP
MEDLINE INDUSTRIES, INC.
DYNJ82358A
In Commercial Distribution

  • 40195327545148 ()
  • 10195327545147 ()
DYNJ82358A

  • General surgical procedure kit, non-medicated, single-use
KNEE ARTHROSCOPY WITH LIPOGEMS
MEDLINE INDUSTRIES, INC.
DYNJ85856
In Commercial Distribution

  • 40195327559510 ()
  • 10195327559519 ()
DYNJ85856

  • General surgical procedure kit, non-medicated, single-use
Extension Set with Luerlocks
Codan US Corporation
BC 575
In Commercial Distribution

  • 10897891001356 ()
  • 897891001359 ()


  • Intravenous administration tubing extension set
Extension Set with Luerlock
Codan US Corporation
BC 541
In Commercial Distribution

  • 897891001335 ()
  • 10897891001332 ()


  • Intravenous administration tubing extension set
Straight Scraper with Window
Seaspine Orthopedics Corporation
SR-1043
In Commercial Distribution

  • 10889981308780 ()
SR-1043

  • Bone file/rasp, manual, reusable
Inserter With Stop, Spacer
Seaspine Orthopedics Corporation
86-0014
Not in Commercial Distribution

  • 10889987164557 ()
86-0014

  • Orthopaedic rod reducer
Easyliner with Coolmax 3mm
Alps South, LLC
ELFC38-3
In Commercial Distribution

  • 00713980013617 ()


  • External limb prosthesis socket liner
with ~15 Balanced Heprin
WESTMED, INC.
3100-31
In Commercial Distribution

  • 00709078004537 ()
  • 00709078004599 ()


  • Arterial blood sampling kit
Cone Adapter with hole
Jaeger Medical GmbH
V-707723
In Commercial Distribution

  • 14250892903795 ()
V-707723

  • Pulmonary function analysis system, adult
ABL800 FLEX with crea
Radiometer Medical ApS
393-801
In Commercial Distribution

  • 05700693938011 ()
393-801

  • Multiple clinical chemistry analyser IVD, laboratory
For Use with 80-0006.
POLARISAR, INC.
50-0015
In Commercial Distribution

  • 00850046497209 ()
50-0015

  • Orthopaedic surgical procedure kit, non-medicated, reusable
For Use with 80-0006.
POLARISAR, INC.
50-0014
In Commercial Distribution

  • 00850046497193 ()
50-0014

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Instrument organizer with post
General Hospital Supply Corp
0117
Not in Commercial Distribution

  • 10850045406032 ()
  • 00850045406035 ()
0117

  • Surgical instrument interim-placement holder, single-use
Instrument organizer with post
General Hospital Supply Corp
0112
In Commercial Distribution

  • 10850045406025 ()
  • 00850045406028 ()
0112

  • Surgical instrument interim-placement holder, single-use
Instrument organizer with post
General Hospital Supply Corp
0108
Not in Commercial Distribution

  • 00850045406011 ()
  • 10850045406018 ()
0108

  • Surgical instrument interim-placement holder, single-use
Steerable Catheter with Electrodes
ST. JUDE MEDICAL, INC.
DS3H010-38
In Commercial Distribution

  • 05415067032287 ()

  • Catheter Gauge: 10.5000 French
DS3H010-38

  • Vascular guide-catheter, single-use
BASIN PACK WITH GOWNS
MEDLINE INDUSTRIES, INC.
DYNJ44070A
In Commercial Distribution

  • 10889942249589 ()
DYNJ44070A

  • General surgical procedure kit, non-medicated, reusable
Inserter with Key Bump
Foundation Fusion Solutions, LLC
T05-01
In Commercial Distribution

  • 00850026642001 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Guide Tube with Tracker
Fusion Robotics, LLC
1010
In Commercial Distribution

  • 00850026574142 ()


  • Robotic surgical navigation system
Electrophysiology Catheter with Lumen
ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
401134
In Commercial Distribution

  • 05414734201209 ()

  • Catheter Gauge: 7 French
401134

  • Cardiac mapping catheter, percutaneous, single-use
Electrophysiology Catheter with Lumen
ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
401130
In Commercial Distribution

  • 05414734201179 ()

  • Catheter Gauge: 7 French
401130

  • Cardiac mapping catheter, percutaneous, single-use
Electrophysiology Catheter with Lumen
ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
401137
In Commercial Distribution

  • 05414734201223 ()

  • Catheter Gauge: 7 French
401137

  • Cardiac mapping catheter, percutaneous, single-use
Electrophysiology Catheter with Lumen
ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
401133
In Commercial Distribution

  • 05414734201193 ()

  • Catheter Gauge: 7 French
401133

  • Cardiac mapping catheter, percutaneous, single-use
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