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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LP20-CONFIGURED,WITH PACING,ENGLISH
PHYSIO-CONTROL, INC.
99402
Not in Commercial Distribution

  • 00721902505140 ()
99402-000016

  • Physiologic-monitoring defibrillation system
LP20-CONFIGURED,WITH PACING,ENGLISH
PHYSIO-CONTROL, INC.
97402
Not in Commercial Distribution

  • 00721902665233 ()
97402-000002

  • Physiologic-monitoring defibrillation system
ANGIO WITH AUXILIARY PACK
Cardinal Health 200, LLC
SAN73ATKAJ
In Commercial Distribution

  • 50198956016185 ()
  • 10198956016187 ()
SAN73ATKAJ

  • Angiography kit
SURGERY PACK WITH GOWN
Cardinal Health 200, LLC
SBA40SPAR1
In Commercial Distribution

  • 50195594098801 ()
  • 10195594098803 ()
SBA40SPAR1

  • General surgical procedure kit, non-medicated, single-use
5MM Cannula with Obturator
LSI Solutions, Inc.
081890
In Commercial Distribution

  • 00850012846413 ()
081890

  • Pleuroscopic/mediastinoscopic access cannula, reusable
OB KIT WITH SCISSORS
MORRISON MEDICAL, LTD
0965-C
In Commercial Distribution

  • 00647921096516 ()
0965-C

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, 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
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
401133
In Commercial Distribution

  • 05414734201193 ()

  • Catheter Gauge: 7 French
401133

  • Cardiac mapping catheter, percutaneous, single-use
Electrophysiology Catheter with Lumen
ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
401132
In Commercial Distribution

  • 05414734201186 ()

  • Catheter Gauge: 7 French
401132

  • 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
C-Arm Kit with Clips
EXACT MEDICAL MANUFACTURING, INC.
D4429
Not in Commercial Distribution

  • 00850024023048 ()
  • 00850024023031 ()
D4429

  • Medical equipment/instrument drape, 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
Hands-Free Arm with clamp
Accuvein Inc.
HF510
In Commercial Distribution

  • 00850019808049 ()


  • Transportable medical equipment stand, non-powered
ABL800 FLEX with crea
Radiometer Medical ApS
393-801
In Commercial Distribution

  • 05700693938011 ()
393-801

  • Multiple clinical chemistry analyser IVD, laboratory
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
EZ-Advancer 14FR with PVP
HR PHARMACEUTICALS INC.
31114
In Commercial Distribution

  • 50850025153275 ()
  • 00850025153270 ()
31114

  • Single-administration urethral catheterization kit, single-use
FEMORAL WITH FLOW SWITCH
MEDLINE INDUSTRIES, INC.
DYNJ45673A
In Commercial Distribution

  • 40889942179887 ()
  • 10889942179886 ()
DYNJ45673A

  • General surgical procedure kit, non-medicated, reusable
Arm Sling with Immobilizer
BROWNMED, INC.
A30141
In Commercial Distribution

  • 00649833301412 ()


  • Suspension arm sling
PIV WITH ULTRASOUND KIT
MEDLINE INDUSTRIES, INC.
DYNDC2399
In Commercial Distribution

  • 10889942365760 ()
DYNDC2399

  • General surgical procedure kit, non-medicated, reusable
SHOULDER PACK WITH POUCH
MEDLINE INDUSTRIES, INC.
DYNJ48235J
In Commercial Distribution

  • 10193489876994 ()
  • 40193489876995 ()
DYNJ48235J

  • General surgical procedure kit, non-medicated, single-use
PIV WITH ULTRASOUND KIT
MEDLINE INDUSTRIES, INC.
DYNDC2399A
In Commercial Distribution

  • 10889942446933 ()
  • 40889942446934 ()
DYNDC2399A

  • General surgical procedure kit, non-medicated, reusable
DRESSING CHANGE WITH STATLOCK
MEDLINE INDUSTRIES, INC.
DYNDC2448
In Commercial Distribution

  • 40889942446637 ()
  • 10889942446636 ()
DYNDC2448

  • General surgical procedure kit, non-medicated, single-use
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
PREP TRAY WITH CHG
MEDLINE INDUSTRIES, INC.
DYNDA2782A
In Commercial Distribution

  • 10193489846119 ()
DYNDA2782A

  • General surgical procedure kit, non-medicated, single-use
PREP TRAY WITH CHG
MEDLINE INDUSTRIES, INC.
DYNDA2782B
In Commercial Distribution

  • 10193489864410 ()
  • 40193489864411 ()
DYNDA2782B

  • General surgical procedure kit, non-medicated, single-use
Bird Beak with Cutter
HU-FRIEDY MFG. CO., LLC
678-325
In Commercial Distribution

  • 10889950003753 ()
678-325

  • Orthodontic pliers
System Controller with Footswitch
RELIGN CORPORATION
R-10001
In Commercial Distribution

  • 00859273007014 ()
R-10001

  • Arthroscopic shaver/electrosurgical system generator
Monitor with Touch Screen
MEDICAPTURE, INC.
MTS156
In Commercial Distribution

  • 00859151005057 ()
MTS156

  • Image display unit, colour
Spy Elite With SPY-Q
Novadaq Technologies Inc
LC3000
In Commercial Distribution

  • 00858701006025 ()
LC3000

  • Surgical video camera
PERI GYN WITH POUCH
MEDLINE INDUSTRIES, INC.
DYNJ80303A
In Commercial Distribution

  • 40195327070725 ()
  • 10195327070724 ()
DYNJ80303A

  • General surgical procedure kit, non-medicated, single-use
Hemacytometer, with cover glass
LW SCIENTIFIC, INC.
CTL-HEMM-GLDR
In Commercial Distribution

  • 00664816000212 ()
CTL-HEMM-GLDR

  • Microscope counting chamber IVD
PERI GYN WITH POUCH
MEDLINE INDUSTRIES, INC.
DYNJ80303
In Commercial Distribution

  • 40195327022083 ()
  • 10195327022082 ()
DYNJ80303

  • General surgical procedure kit, non-medicated, single-use
Lanyard with detachable loop
DermLite LLC
AL-P
In Commercial Distribution

  • 00855997006517 ()
AL-P

  • Dermatoscope, optical
Cryosurgical equipment with accessories
Cortex Technology ApS
19
In Commercial Distribution

  • 05710188020022 ()
E0200219

  • General cryosurgical system, cryogen gas, mechanical
Cryosurgical device with accessories
Cortex Technology ApS
19
In Commercial Distribution

  • 05710188020015 ()
E0200119

  • General cryosurgical system, cryogen gas, mechanical
SHOWER KIT WITH CHG
MEDLINE INDUSTRIES, INC.
PACG1061
In Commercial Distribution

  • 10889942931521 ()
  • 40889942931522 ()
PACG1061

  • General surgical procedure kit, non-medicated, single-use
FTSG COOLER WITH LABELS
MEDLINE INDUSTRIES, INC.
DYNJ907872A
In Commercial Distribution

  • 10195327105594 ()
DYNJ907872A

  • General surgical procedure kit, non-medicated, single-use
SHOULDER PACK WITH POUCH
MEDLINE INDUSTRIES, INC.
DYNJ48235G
In Commercial Distribution

  • 10889942899234 ()
DYNJ48235G

  • General surgical procedure kit, non-medicated, single-use
Bulb with Chrome-plated Air-valve
REPROCESSING PRODUCTS CORPORATION
BB00-0001
In Commercial Distribution

  • 00858293006489 ()


  • Blood pressure cuff inflator, manual
IV MODULE WITH EVERYTHING
MEDLINE INDUSTRIES, INC.
ACC010604
In Commercial Distribution

  • 40195327153824 ()
  • 10195327153823 ()
ACC010604

  • General surgical procedure kit, non-medicated, single-use
Transformer with Output Cord
MICROLIGHT CORPORATION OF AMERICA
ML-830-02-004
In Commercial Distribution

  • 00859626006121 ()
ML-830-02-004

  • Isolation transformer
e-Ruler with Stop Locks
JORDCO INC
ERUL-s
In Commercial Distribution

  • 00859611006112 ()
ERUL-S

  • Medical ruler, reusable
CATHETER REINF WITH CONNECTOR
MEDLINE INDUSTRIES, INC.
EPIREINF29C
In Commercial Distribution

  • 40195327114368 ()
  • 10195327114367 ()
EPIREINF29C

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