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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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The M5, Single Package with Single Flat Panel Monitor Mount, with Hub, Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191405 ()
LM24T

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The M7 Single Package with Single High Density Flat Panel Monitor with Hub is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995190460 ()
LM29N

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The M5, Single Package with Single Flat Panel Monitor Mount, with Hub Spacer is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191399 ()
LM24

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
With Fluid Ciculation - Thermal Balloon Ablation Silicone Catheter with Fluid Circulation. For use only with GYNECARE THERMACHOICE TM UBT System Controller
Ethicon Inc.
TC003
Not in Commercial Distribution

  • 20705031050737 ()
  • 10705031050730 ()
TC003

  • Circulating-fluid endometrial-ablation catheter
EpiSpin Lock Tuohy with backeye and wings 18G x 90mm, Sprotte Standard with
Pajunk GmbH Medizintechnologie
0021351-30
Not in Commercial Distribution

  • 14048223009410 ()
  • 04048223009413 ()
0021351-30

  • Epidural/intrathecal anaesthesia set, non-medicated
EpiSpin Lock Tuohy with backeye and wings 18G x 90mm, Sprotte Standard with
Pajunk GmbH Medizintechnologie
0011351-30
Not in Commercial Distribution

  • 14048223009342 ()
  • 04048223009345 ()
0011351-30

  • Epidural/intrathecal anaesthesia set, non-medicated
EpiSpin Lock Tuohy with backeye and wings 17G x 90mm Sprotte Standard with
Pajunk GmbH Medizintechnologie
0011351-20
Not in Commercial Distribution

  • 14048223009335 ()
  • 04048223009338 ()
0011351-20

  • Epidural/intrathecal anaesthesia set, non-medicated
EpiSpin Lock Tuohy with backeye and wings 18G x 90mm, Sprotte Standard with
Pajunk GmbH Medizintechnologie
0001351-30
Not in Commercial Distribution

  • 14048223009151 ()
  • 04048223009154 ()
0001351-30

  • Epidural/intrathecal anaesthesia set, non-medicated
Sentrus Insufflation Tubing with CO2 Connector, Insufflation tubing with CO2 connection hose (Olympus)
Yangzhou Fartley Medical Instrument Technology Co., Ltd
FTL-EFC-O-D1-B1
In Commercial Distribution

  • 16936603231163 ()
  • 06936603231166 ()
SEN-INT-O-CO2

  • Endoscopic insufflation tubing set, single-use
Coffee PU, With bag, With connector Double tube Large Adult Long Range 33-47cm
Orantech Inc.
BPN-80BD-W38
In Commercial Distribution

  • 06941691980735 ()


  • Blood pressure cuff, reusable
Coffee PU leather, With inflation bag, Double tube, With connector Adult Range 25-35cm
Orantech Inc.
BPN-50BD-WD11
In Commercial Distribution

  • 06941691964490 ()


  • Blood pressure cuff, reusable
Coffee PU leather, With inflation bag, Double tube, With connector Adult Range 25-35cm
Orantech Inc.
BPN-50BD-WD08
In Commercial Distribution

  • 06941691964384 ()


  • Blood pressure cuff, reusable
Coffee PU leather, With inflation bag, Single tube,With connector Adult Range 25-35cm
Orantech Inc.
BPN-50BS-W01M
In Commercial Distribution

  • 06941691963387 ()


  • Blood pressure cuff, reusable
Back w/armrest-padded full length for Stool, complete with hardware, - with uph back
BRYDAN MEDICAL HOLDINGS
90086
In Commercial Distribution

  • 00853301008295 ()


  • Chair/stool armrest
SPUR II Infant with closed reservoir, with no face mask 12 pcs/box
Ambu A/S
540200000
In Commercial Distribution

  • 05707480033843 ()
  • 05707480017928 ()

  • Infant
540200000

  • Pulmonary resuscitator, manual, single-use
Bitestrong Bite Blocks with Nasal Oxygen Delivery, 18 mm, single use, with stap
Batrik Medical Manufacturing Inc
BO2
In Commercial Distribution

  • 00690521000100 ()
BO2

  • Endoscopic bite block, basic, single-use
Safety blood collection set with pre-attached holder, 23G*3/4" with 12" tubing
KB Medical (group), Inc.
SBCN23-1H
In Commercial Distribution

  • 00850016172372 ()


  • Blood collection set, invasive
Safety blood collection set with pre-attached holder, 21G*3/4" with 12" tubing
KB Medical (group), Inc.
SBCN21-1H
In Commercial Distribution

  • 00850016172341 ()


  • Blood collection set, invasive
Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600IU/ml FSH
Terumo Europe NV
BS-N1A2713U
In Commercial Distribution

  • 55413206220248 ()
  • 35413206220244 ()
  • 05413206220243 ()

  • Syringe Volume: 1 Milliliter
  • Needle Length: 12 Millimeter
  • Needle Outer Diameter: 0.4 Millimeter
  • Needle Length: 0.5 Inch
  • Needle Gauge: 27 Gauge
  • Regular wall
BS-N1A2713U

  • Metered-delivery hypodermic syringe
Gastric Lavage Kit with 32fr Tubes and (2) 25g Activated Charcoal with Aqua
ETHOX MEDICAL, LLC
950095603
In Commercial Distribution

  • 20889483150044 ()
  • 10889483150047 ()

  • Catheter Gauge: 32 French


  • Gastric lavage kit
Safety blood collection set with pre-attached holder, 25G*3/4" with 12" tubing
KB Medical (group), Inc.
SBCN25-1H
In Commercial Distribution

  • 00850016172969 ()


  • Blood collection set, invasive
microTargeting Insertion Tube with Stylet, nonsterile, at target, for use with Nexframe/Nexdrive
FHC, INC.
66-IT(DB12)-00521
In Commercial Distribution

  • 00873263005217 ()

  • Lumen/Inner Diameter: 1.6 Millimeter
  • Outer Diameter: 1.83 Millimeter
  • Length: 211.6 Millimeter
66-IT(DB12)

  • Intracerebral cannula, implantable
With extra reservoir bag, with B/V filter, 7' tubing w/threaded nut
WESTMED, INC.
0329
In Commercial Distribution

  • 10709078000734 ()
  • 00709078000737 ()


  • Heat/moisture exchanger/microbial medical gas filter
  • Nebulizing system delivery set, single-use
Coffee PU leather, With inflation bag, Double tube, With connector Adult Range 25-35cm
Orantech Inc.
BPN-50BD-W1011
In Commercial Distribution

  • 06941691964582 ()


  • Blood pressure cuff, reusable
Coffee PU leather, With inflation bag, Single tube,With connector Adult Range 25-35cm
Orantech Inc.
BPN-50BS-W10
In Commercial Distribution

  • 06941691964292 ()


  • Blood pressure cuff, reusable
Coffee PU leather, With inflation bag, Single tube,With connectorLarge Adult Range 33-47cm
Orantech Inc.
BPN-70BS-W01M
In Commercial Distribution

  • 06941691963400 ()


  • Blood pressure cuff, reusable
Coffee PU leather, With inflation bag, Single tube,With connector SmallAdult Range 20-28cm
Orantech Inc.
BPN-40BS-W01M
In Commercial Distribution

  • 06941691963370 ()


  • Blood pressure cuff, reusable
Patient Kit, with 1600HF cannula and Bubble Humidifier (6-15 LPM) with 6 PSI
SALTER LABS
SO-2052
In Commercial Distribution

  • 10607411940689 ()
  • 00607411940682 ()

  • Adult
SO-2052

  • Non-heated respiratory humidifier
PerformaTrak Mask with Entrainment Elbow, with 4 Point Headgear, Single Use, China, Medium
Respironics, Inc.
PerformaTrak EE Mask w 4 PT Headgr, SU, Medium, CN
Not in Commercial Distribution

  • 00606959009431 ()
CN1012574

  • CPAP/BPAP face mask, single-use
AF531 Mask with Standard Elbow, with 4 Point Headgear, Single Use, China, Large
Respironics, Inc.
AF531 Mask w/SE, w/4 PT Headgear, SU, Large, CN
Not in Commercial Distribution

  • 30606959008701 ()
  • 00606959008700 ()
1119076

  • CPAP/BPAP face mask, single-use
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