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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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DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT
Cardiovascular Systems, Inc.
DBEC-125
In Commercial Distribution

  • 10850026568698 ()

  • Low Speed 80krpm
  • Medium Speed krpm
  • High Speed 120krpm
  • Crown Type Classic
  • Max OD 0.0495in
  • Intro Sheath 6Fr
  • Crown Diameter 1.25mm
  • Nose Length 5mm
  • Shaft Length: 135 Centimeter
  • Guidewire Size OD 0.012in
7-10098-01

  • Mechanical atherectomy system, coronary, line-powered
3F (1.1MM ID) X 3CM3F (1.1MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/60CM STEEL WIREW/60CM STEEL WI & 22GA SAFETY NEEDLE
Medical Components, Inc.
MR1903622S
Not in Commercial Distribution

  • 50884908104290 ()
  • 30884908104296 ()
  • 00884908104295 ()
MR1903622S

  • Vascular catheter introduction needle
3F (1.1MM ID) X 3CM3F (1.1MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/60CM STEEL WIREW/60CM STEEL WI & 24GA SAFETY NEEDLE
Medical Components, Inc.
MR1903624S
Not in Commercial Distribution

  • 50884908104283 ()
  • 30884908104289 ()
  • 00884908104288 ()
MR1903624S

  • Vascular catheter introduction needle
2F (0.7MM ID) X 2CM2F (0.7MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/60CM STEEL WIREW/60CM STEEL WI & 22GA SAFETY NEEDLE
Medical Components, Inc.
MR1902622S
Not in Commercial Distribution

  • 30884908104197 ()
  • 00884908104196 ()
  • 50884908104191 ()
MR1902622S

  • Vascular catheter introduction needle
2F (0.7MM ID) X 2CM2F (0.7MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/60CM STEEL WIREW/60CM STEEL WI & 24GA SAFETY NEEDLE
Medical Components, Inc.
MR1902624S
Not in Commercial Distribution

  • 30884908104180 ()
  • 00884908104189 ()
  • 50884908104184 ()
MR1902624S

  • Vascular catheter introduction needle
4-hour ID of Enterobacteriaceae. API®strips give accurate ID based on extensive databases and are standardized, easy-to-use test systems.
BIOMERIEUX SA
RAPID 20 E™
In Commercial Distribution

  • 03573026048617 ()
  • 03573026588526 ()


  • Multiple gram negative bacteria species culture isolate identification IVD, kit
Adult Adapter - 15mm ID/22mm OD x15mm ID/22mm OD. Fits components of adult ventilator circuits. Molded of polycarbonate. Reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
KC 105
In Commercial Distribution

  • M996KC1052 ()
  • M996KC1050 ()
KC 105

  • Straight/elbow breathing circuit connector, reusable
Reducing Adapter for use in breathing/ventilator circuit. 15mm ID x 22mm ID. Molded of polystyrene butadiene. Single Patient Use.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SG 101-D
In Commercial Distribution

  • M996SG101D6 ()
  • M996SG101D0 ()
  • M996SG101D4 ()
SG 101-D

  • Straight/elbow breathing circuit connector, single-use
Reducing Connector - 15mm ID x 10mm ID. Fits components of pediatric to neonatal ventilator circuits. Molded of silicone rubber. Reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
PF 1510
In Commercial Distribution

  • M996PF15102 ()
  • M996PF15100 ()
  • M996PF15105 ()
PF 1510

  • Straight/elbow breathing circuit connector, reusable
7F (2.3MM ID) X 10CM7F (2.3MM ID TEARAWAY INTRODUCER SETTEARAWAY W/NITINOL GUIDEWIREW/NITINOL GUI W/RADIOPAQUE TIPW/RADIOPAQUE TIP
Medical Components, Inc.
DMR210780
Not in Commercial Distribution

  • 50884908145514 ()
  • 30884908145510 ()
  • 00884908145519 ()
DMR210780

  • Vascular catheter introduction needle
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