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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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Motion composites - 00811774000017

wheelchair mechanical
Motion Composites Inc
Helio A7
In Commercial Distribution

  • 00811774000017 ()


  • Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

BD QUINCKE Spinal Needles - 00382904051822

NEEDLE SPINAL S/SU 20GA 3-1/2IN QUINCKE
BECTON, DICKINSON AND COMPANY
405182
In Commercial Distribution

  • 50382904051827 ()
  • 00382904051822 ()
  • 30382904051823 ()

  • Length: 3.5 Inch
405182

  • Spinal needle, single-use

BD QUINCKE Spinal Needles - 00382904051815

NEEDLE SPINAL S/SU 22GA 3-1/2IN QUINCKE
BECTON, DICKINSON AND COMPANY
405181
In Commercial Distribution

  • 50382904051810 ()
  • 00382904051815 ()
  • 30382904051816 ()

  • Length: 3.5 Inch
405181

  • Spinal needle, single-use
  • Evacuated blood collection tube IVD, anticoagulant/antiglycolytic

BD QUINCKE Spinal Needles - 00382904051808

NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE
BECTON, DICKINSON AND COMPANY
405180
In Commercial Distribution

  • 50382904051803 ()
  • 00382904051808 ()
  • 30382904051809 ()

  • Length: 3.5 Inch
405180

  • Spinal needle, single-use

TUBING WITH T-PIECE WITH LUER CAP - 05030267086986

TUBING WITH T-PIECE WITH LUER CAP
Intersurgical Incorporated
9451830
In Commercial Distribution

  • 05030267091256 ()
  • 05030267086986 ()


  • Gas-sampling/monitoring respiratory tubing, single-use

SonoVision - 00860001239300

SonoVision Accessory Kit
Tissue Differentiation Intelligence LLC
100039
In Commercial Distribution

  • 00860001239300 ()


  • Interventional radiology percutaneous-access kit, reusable

DS6 - 00850064651102

Depth Sensor
Foresite Healthcare, LLC
DS6-DB
In Commercial Distribution

  • 00850064651102 ()


  • Biomechanical function analysis system, motion-tracking

Bed4 - 00850064651096

Bed Sensor
Foresite Healthcare, LLC
Bed4-UBS
In Commercial Distribution

  • 00850064651096 ()


  • Bed/chair occupant movement pressure/vibration sensor

Bed4 - 00850064651089

Bed Sensor
Foresite Healthcare, LLC
Bed4-RPS
In Commercial Distribution

  • 00850064651089 ()


  • Bed/chair occupant movement pressure/vibration sensor

Bed4 - 00850064651072

Bed Sensor
Foresite Healthcare, LLC
Bed4-UB
In Commercial Distribution

  • 00850064651072 ()


  • Bed/chair occupant movement pressure/vibration sensor

DS6 - 00850064651065

Depth Sensor
Foresite Healthcare, LLC
DS6-UB
In Commercial Distribution

  • 00850064651065 ()


  • Biomechanical function analysis system, motion-tracking

DS6 - 00850064651058

Depth Sensor
Foresite Healthcare, LLC
DS6-RP
In Commercial Distribution

  • 00850064651058 ()


  • Bed/chair occupant movement pressure/vibration sensor

DS6 - 00850064651041

Depth Sensor
Foresite Healthcare, LLC
DS6-UB
In Commercial Distribution

  • 00850064651041 ()


  • Bed/chair occupant movement pressure/vibration sensor

Bed4 - 00850064651034

Depth Sensor
Foresite Healthcare, LLC
Bed4-RPS
In Commercial Distribution

  • 00850064651034 ()


  • Bed/chair occupant movement pressure/vibration sensor

MDS - 00850064651027

Mobile Depth Sensor
Foresite Healthcare, LLC
MDS
In Commercial Distribution

  • 00850064651027 ()


  • Biomechanical function analysis system, motion-tracking

DS6 - 00850064651010

Depth Sensor
Foresite Healthcare, LLC
DS6
In Commercial Distribution

  • 00850064651010 ()


  • Biomechanical function analysis system, motion-tracking

DS5 - 00850064651003

Depth Sensor
Foresite Healthcare, LLC
DS5-RN
In Commercial Distribution

  • 00850064651003 ()


  • Biomechanical function analysis system, motion-tracking

Medline - 10193489021165

1ML ORAL SYRINGE
MEDLINE INDUSTRIES, INC.
NS1PC
In Commercial Distribution

  • 30193489021169 ()
  • 10193489021165 ()
  • 20193489021162 ()

  • Total Volume: 1 Milliliter
NS1PC

  • Irrigation syringe

Medline - 30193489181689

SYRINGE,LUER LOCK,STERILE,3ML,PUMPC
MEDLINE INDUSTRIES, INC.
SYR103010PC
In Commercial Distribution

  • 10193489181685 ()
  • 20193489181682 ()
  • 30193489181689 ()
SYR103010PC

  • General-purpose syringe, single-use

Medline - 30193489181672

SYRINGE,LUER LOCK,STERILE,5ML,PUMPC
MEDLINE INDUSTRIES, INC.
SYR105010PC
In Commercial Distribution

  • 10193489181678 ()
  • 20193489181675 ()
  • 30193489181672 ()
SYR105010PC

  • General-purpose syringe, single-use

Medline - 30193489181665

SYRINGE,LUER LOCK,STERILE,10ML, PUMPC
MEDLINE INDUSTRIES, INC.
SYR110010PC
In Commercial Distribution

  • 10193489181661 ()
  • 20193489181668 ()
  • 30193489181665 ()
SYR110010PC

  • General-purpose syringe, single-use

Medline - 30193489181658

SYRINGE,LUER LOCK,STERILE,20ML,PUMPC
MEDLINE INDUSTRIES, INC.
SYR120010PC
In Commercial Distribution

  • 10193489181654 ()
  • 20193489181651 ()
  • 30193489181658 ()
SYR120010PC

  • General-purpose syringe, single-use

Medline - 30193489181641

SYRINGE,LUER LOCK,STERILE,30ML,PUMPC
MEDLINE INDUSTRIES, INC.
SYR130010PC
In Commercial Distribution

  • 10193489181647 ()
  • 20193489181644 ()
  • 30193489181641 ()
SYR130010PC

  • General-purpose syringe, single-use

Medline - 30193489181634

SYRINGE,LUER LOCK,STERILE,60ML,PUMPC
MEDLINE INDUSTRIES, INC.
SYR160010PC
In Commercial Distribution

  • 10193489181630 ()
  • 20193489181637 ()
  • 30193489181634 ()
SYR160010PC

  • General-purpose syringe, single-use

Strong Manufacturers - 00850040791174

Manual stethoscope used to project the sounds associated with the heart, arteries, veins and other internal organs. Single head, yellow, not made with natural rubber latex. Case of 25 each.
Strong Medical Partners LLC
7101
In Commercial Distribution

  • 10850040791171 ()
  • 00850040791174 ()
7101

  • Mechanical external stethoscope

Artemis with ProFuse - 00860009734838

Artemis along with the Needle Guide Attachment is used for image-guided interventional and diagnostic procedures of the prostate gland. It provides 2D and 3D visualization of Ultrasound (US) images and the ability to fuse and register these images with those from other imaging modalities such as Ultrasound, Magnetic Resonance, Computed Tomography, etc. It also provides the ability to display a simulated image of a tracked insertion tool such as a biopsy needle, guidewire or probe on a computer monitor screen that shows images of the target organ and the current and the projected future path of the interventional instrument taking into account patient movement. The software also provides a virtual grid on the live ultrasound for performing systematic sampling of the target organ. Other software features include patient data management, multi-planar reconstruction, segmentation, image measurements, 2D/3D image registration, reporting, and pathology management. Artemis is intended for treatment planning and guidance for clinical, interventional and/or diagnostic procedures. The device is intended to be used in interventional and diagnostic procedures in a clinical setting. Example procedures include, but are not limited to image fusion for diagnostic clinical examinations and procedures, soft tissue biopsies, soft tissue ablations and placement of fiducial markers. Artemis is also intended to be used for patients in active surveillance to keep track of previous procedures information and outcomes.
Eigen Health Services LLC
2.0 HD
In Commercial Distribution

  • 00860009734838 ()


  • Rectal ultrasound navigational image processor

Flex-MI with Electrodes - 00859718007289

Power muscle stimulator with Electrodes
Emsi
FLEMC0001
In Commercial Distribution

  • 00859718007289 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
  • Transcutaneous electrical stimulation electrode, single-use

ToggleLoc With Ziploop - 00880304453364

No Description
Biomet Orthopedics, LLC
904755
In Commercial Distribution

  • 00880304453364 ()
904755

  • Tendon/ligament bone anchor, non-bioabsorbable

ToggleLoc With Ziploop - 00880304464858

No Description
Biomet Orthopedics, LLC
904754
In Commercial Distribution

  • 00880304464858 ()
904754

  • Tendon/ligament bone anchor, non-bioabsorbable

TOGGLELOC WITH ZIPLOOP - 00880304464773

No Description
Biomet Sports Medicine, LLC
909848
In Commercial Distribution

  • 00880304464773 ()
909848

  • Ligament reconstruction instrument set, reusable

ToggleLoc With Ziploop - 00880304464223

No Description
Biomet Orthopedics, LLC
904756
In Commercial Distribution

  • 00880304464223 ()
904756

  • Tendon/ligament bone anchor, non-bioabsorbable

TOGGLELOC WITH ZIPLOOP - 00880304676947

No Description
Biomet Sports Medicine, LLC
110017308
In Commercial Distribution

  • 00880304676947 ()

  • 2.9 MM
110017308

  • Tendon/ligament bone anchor, non-bioabsorbable

TOGGLELOC WITH ZIPLOOP - 00880304676930

No Description
Biomet Orthopedics, LLC
110010384
In Commercial Distribution

  • 00880304676930 ()

  • 2.9 MM
110010384

  • Tendon/ligament bone anchor, non-bioabsorbable

TOGGLELOC WITH ZIPLOOP - 00880304478923

No Description
Biomet Sports Medicine, LLC
909874
In Commercial Distribution

  • 00880304478923 ()

  • 4.5 MM
909874

  • Ligament bone anchor

TOGGLELOC WITH ZIPLOOP - 00880304472709

No Description
Biomet Sports Medicine, LLC
909849
In Commercial Distribution

  • 00880304472709 ()
909849

  • Ligament reconstruction instrument set, reusable

ToggleLoc with Ziploop - 00880304470361

No Description
Biomet Orthopedics, LLC
909854
In Commercial Distribution

  • 00880304470361 ()

  • 4.5 MM
909854

  • Ligament reconstruction instrument set, reusable

ToggleLoc with Ziploop - 00880304469471

No Description
Biomet Orthopedics, LLC
904753
In Commercial Distribution

  • 00880304469471 ()

  • 4.5 MM
904753

  • Tendon/ligament bone anchor, non-bioabsorbable

Probe with roller - 14897076722843

No Description
TENS PLUS INDUSTRIAL COMPANY
BY2347
In Commercial Distribution

  • 14897076722843 ()


  • External manual massager, clinical

COVERLET WITH ZIPPER - 00850520008211

Silver Coverlet with Zipper
KREG MEDICAL INC.
ASM100118
In Commercial Distribution

  • 00850520008211 ()


  • Waterproof bed mattress cover, reusable
  • Antimicrobial bed mattress cover

COVERLET WITH ZIPPER - 00850520008204

Deep Purple Coverlet with Zipper
KREG MEDICAL INC.
ASM100117
In Commercial Distribution

  • 00850520008204 ()


  • Waterproof bed mattress cover, reusable
  • Antimicrobial bed mattress cover
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