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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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INTRODUCER ONE STEP 4FR X 45CM
STRADIS MEDICAL, LLC
525-029
Not in Commercial Distribution

  • M7525250292 ()
  • M7525250291 ()

  • Length: 45 Centimeter
  • Catheter Gauge: 4 French
525-029

  • Vascular catheter introduction set, nonimplantable
ONE STEP INTRODUCER KIT
STRADIS MEDICAL, LLC
525-028
Not in Commercial Distribution

  • M7525250282 ()
  • M7525250281 ()

  • Length: 45 Centimeter
  • Catheter Gauge: 4 French
525-028

  • Cardiac/peripheral vascular guidewire, single-use
INTRODUCER KIT, 4FRX20CM GW .018"X70CM MANDREL 21GX2.75 ECHO NEEDLE ONE STEP 10/BX
STRADIS MEDICAL, LLC
525-027
Not in Commercial Distribution

  • M7525250272 ()
  • M7525250271 ()

  • Catheter Gauge: 4 French
  • Needle Gauge: 21 Gauge
  • Length: 20 Centimeter
525-027

  • Vascular catheter introduction set, nonimplantable
No Description
STRADIS MEDICAL, LLC
525-019
In Commercial Distribution

  • M7525250191 ()
  • M7525250190 ()


  • Fluid transfer set, general-purpose
No Description
STRADIS MEDICAL, LLC
515-001
Not in Commercial Distribution

  • M7525150010 ()
  • M7525150011 ()


  • General surgical procedure kit, non-medicated, single-use
Pen Needle Kit
STRADIS MEDICAL LLC
511390
In Commercial Distribution

  • M7525113905 ()
  • M7525113900 ()


  • Blood collection set, invasive
Pen Needle Kit
STRADIS MEDICAL LLC
511389
In Commercial Distribution

  • M7525113890 ()
  • M7525113895 ()


  • Blood collection set, invasive
Self-Drilling Screw - Ø1.9 mm x 4 mm (3) [10 PK]
Bioplate, Inc.
81-2094
In Commercial Distribution

  • M3848120941 ()
  • M3848120940 ()
81-2094

  • Craniofacial bone screw, non-bioabsorbable
Flexible Burr Hole Cover - Ø1.9 mm - 18 mm (1), Boxcar - 4 hole - 11 mm (2), Self-Drilling Screw - 4 mm (5) [5 PK]
Bioplate, Inc.
81-2093
In Commercial Distribution

  • M3848120931 ()
  • M3848120930 ()
81-2093

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable
Tera TENS
GF HEALTH PRODUCTS, INC.
GF-TT5
In Commercial Distribution

  • M368GFTT52 ()
  • M368GFTT51 ()


  • Analgesic transcutaneous electrical nerve stimulation system
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