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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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Drill-Reamer Packaged Assembly
Insurgical, Inc.
320-0064-001
In Commercial Distribution

  • 00860007230004 ()
3010001

  • Bone/joint surgical power tool motorized handpiece/set, electric, single-use
NeuraMedica Dural Clips are bioabsorbable surgical clips designed to aid in closure of the dura mater in neurosurgical and orthopedic spine procedures. NeuraMedica Dural Clips are 3mm wide by 4.6mm long. They are applied using a reusable stainless steel applier. The NeuraMedica Applier is a separately-supplied reusable instrument.
Neuramedica Inc.
DC-501
In Commercial Distribution

  • 00860007130403 ()


  • Ligation clip, synthetic polymer, bioabsorbable
Accessory connector to be used with Venturi MicroDry, compatible with Olympus endoscope
GI Scientific LLC
Universal Connector with Auxiliary Jet Connector Olympus
In Commercial Distribution

  • 00860007020926 ()
VDU-06-00023

  • Surgical instrument/endoscope cleaning utensil, reusable
Device Description The sterile disposable, single-use surgical filter consists of a cylindrical container and dual filtrating system. Connection to the suction unit through the tubing is required to operate the device. The Bone Dust Trap is a filtration device for collecting bone dust and particles for subsequent bone graft implantation during various surgical procedures. The device can be emptied and further reused during a single operating procedure on the same patient.
Rim Medical Technologies Incorporated
1
In Commercial Distribution

  • 00860006413903 ()


  • Bone graft harvesting filter
PH Band
Medical Ingenuities, LLC
41111-01
In Commercial Distribution

  • 00860006401702 ()
  • 10860006401709 ()
PHB-001U

  • Radial artery compression device
One handed use No lancing device required Automatic needle retraction Lock out after use prevents needle stick injuries as well as cross-contamination
HOME AIDE DIAGNOSTICS, INC.
TrueCSafety50
In Commercial Distribution

  • 10860006377851 ()
  • 00860006377854 ()

  • Needle Gauge: 30 Gauge


  • Manual blood lancing device, single-use
One handed use No lancing device required Automatic needle retraction Lock out after use prevents needle stick injuries as well as cross-contamination
HOME AIDE DIAGNOSTICS, INC.
TrueCSafety100
In Commercial Distribution

  • 10860006377844 ()
  • 00860006377847 ()

  • Needle Gauge: 30 Gauge


  • Manual blood lancing device, single-use
One handed use No lancing device required Automatic needle retraction Lock out after use prevents needle stick injuries as well as cross-contamination
HOME AIDE DIAGNOSTICS, INC.
PureCSafety50
In Commercial Distribution

  • 10860006377813 ()
  • 00860006377816 ()

  • Needle Gauge: 30 Gauge


  • Manual blood lancing device, single-use
Cervical spinal stenosis curette
Neuro Enterprises, LLC
NE5
In Commercial Distribution

  • 00860006017736 ()


  • Neurosurgical curette, single-use
The MIS Precision Chevron Bunion System™ is a kit designed to allow surgeons to perform a chevron bunion osteotomy, and subsequent fixation of the osteotomy, with a minimally invasive surgical technique. The MIS Precision Chevron Bunion System™ consists of a single, sterile-packaged SKU that contains both implants and instruments needed for the procedure. The implants in the kit are cannulated headless compression screws, made from titanium (Ti-6AL-4V ELI). There are two implants in the kit, however only one is used in a surgical procedure. Two implants are provided to allow the physician to select the proper size for the patient at the time of surgery. The implants are 3.5 mm diameter, with lengths of 24 mm and 27 mm. There are also single-use instruments, made of injection molded polycarbonate, PEEK, and stainless steel included in the MIS Precision Chevron Bunion System™. Instruments include an osteotomy guide (one each for left and right feet), a targeting guide, a screw guide, screwdriver, drill bit, and several K-wires and a guidewire. Additional general surgical instrumentation is utilized, but not part of the RELJA system, such as sagittal saw, drivers, and scalpel.
Relja Innovations LLC
RI-2427-C
In Commercial Distribution

  • 00860005968800 ()


  • Orthopaedic bone screw, non-bioabsorbable, sterile
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