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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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2F (0.7MM ID) X 2 CM2F (0.7MM ID TEARAWAY INTRODUCER SETTEARAWAY W/20CM NITINOL WIREW/20CM NITINO & 22GA NEEDLE
Medical Components, Inc.
MR1902222
Not in Commercial Distribution

  • 50884908104108 ()
  • 30884908104104 ()
  • 00884908104103 ()
MR1902222

  • Vascular catheter introduction needle
2F (0.7MM ID) X 2CM2F (0.7MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/20CM NITINOL WIREW/20CM NITINO & 22GA SAFETY NEEDLE
Medical Components, Inc.
MR1902222S
Not in Commercial Distribution

  • 50884908104092 ()
  • 30884908104098 ()
  • 00884908104097 ()
MR1902222S

  • Vascular catheter introduction needle
2F (0.7MM ID) X 2CM2F (0.7MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/20CM NITINOL WIRE & 24GA SAFETY NEEDLE24GA SAFETY NE
Medical Components, Inc.
MR1902224S
Not in Commercial Distribution

  • 50884908104085 ()
  • 30884908104081 ()
  • 00884908104080 ()
MR1902224S

  • Vascular catheter introduction needle
Scar Aid Fabric Areopexy 2.75" OD x .75 ID x 5.90" L (6.9cm OD x 1.9cm ID) 5 pair
Biodermis LLC
SFLP-51
In Commercial Distribution

  • 00854763005167 ()
SFLP-51

  • Scar-management dressing, reusable
Scar Aid Fabric Areopexy 2.75" OD x .75 ID x 5.90" L (6.9cm OD x 1.9cm ID) 1 pair
Biodermis LLC
SFLP-1
In Commercial Distribution

  • 00854763005150 ()
SFLP-1

  • Scar-management dressing, reusable
The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE13 model is a tablet PC with a 13" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE13
In Commercial Distribution

  • B201CGCORE130 ()
  • B201CGCORE131 ()
CG-CORE-13

  • Ultrasound imaging system workstation
  • Stereotactic surgery system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Portable computer
0.018" Shepherd ES Guidewire - straight 300 cm - 30 gms
Cardiovascular Systems, Inc.
PSP18S-30030
In Commercial Distribution

  • 30850026568685 ()
  • 10850026568681 ()

  • Guidewire Diameter: 0.018 Inch
  • Length: 300 Centimeter
  • Hydrophilic Coating
  • Tip Flex 30 grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10097-08

  • Peripheral vascular guidewire, manual
0.014" Shepherd ES Guidewire - straight 300 cm - 30 gms
Cardiovascular Systems, Inc.
PSP14S-30030
In Commercial Distribution

  • 30850026568661 ()
  • 10850026568667 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 300 Centimeter
  • Tip Flex 30 Grams
  • Tip Shape Straight
  • Hydrophilic Coating
  • Tip Design Polymer Jacket
7-10097-06

  • Peripheral vascular guidewire, manual
0.018" Shepherd ES Guidewire - straight 300 cm - 12 gms
Cardiovascular Systems, Inc.
PSP18S-30012
In Commercial Distribution

  • 30850026568647 ()
  • 10850026568643 ()

  • Guidewire Diameter: 0.018 Inch
  • Length: 300 Centimeter
  • Hydrophilic Coating
  • Tip Flex 12 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10097-04

  • Peripheral vascular guidewire, manual
0.014" Shepherd ES Guidewire - straight 300 cm - 12 gms
Cardiovascular Systems, Inc.
PSP14S-30012
In Commercial Distribution

  • 30850026568623 ()
  • 10850026568629 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 300 Centimeter
  • Hydrophilic Coating
  • Tip Flex 12 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10097-02

  • Peripheral vascular guidewire, manual
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