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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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NA - 04055207033470

LASER GUIDE TUBE ID 0.8MM WL 450MM reusable
Richard Wolf GmbH
825100011
Not in Commercial Distribution

  • 04055207033470 ()

  • Length: 450 Millimeter
  • Lumen/Inner Diameter: 0.8 Millimeter
82510.0011

  • General/multiple surgical laser system beam guide, reusable

SCAR AID - 00854763005167

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 - 00854763005150

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

N/AN/A - 00884908104257

3F (1.1MM ID) X 3CM3F (1.1MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/40CM NITINOL WIREW/40CM NITINO & 22GA SAFETY NEEDLE
Medical Components, Inc.
MR1903422S
Not in Commercial Distribution

  • 30884908104258 ()
  • 00884908104257 ()
  • 50884908104252 ()
MR1903422S

  • Vascular catheter introduction needle

N/AN/A - 00884908104226

3F (1.1MM ID) X 3CM3F (1.1MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/20CM NITINOL WIRE & 22GA SAFETY NEEDLE22GA SAFETY NE
Medical Components, Inc.
MR1903222S
Not in Commercial Distribution

  • 30884908104227 ()
  • 00884908104226 ()
  • 50884908104221 ()
MR1903222S

  • Vascular catheter introduction needle

N/AN/A - 00884908104172

2F (0.7MM ID) X 2 CM2F (0.7MM ID TEARAWAY INTRODUCER SETTEARAWAY W/40CM NITINOL WIREW/40CM NITINO & 22GA NEEDLE
Medical Components, Inc.
MR1902422
Not in Commercial Distribution

  • 50884908104177 ()
  • 30884908104173 ()
  • 00884908104172 ()
MR1902422

  • Vascular catheter introduction needle

N/AN/A - 00884908104103

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

N/AN/A - 00884908104097

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

N/AN/A - 00884908104240

3F (1.1MM ID) X 3CM3F (1.1MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/40CM NITINOL WIRE & 24GA SAFETY NEEDLE24GA SAFETY NE
Medical Components, Inc.
MR1903424S
Not in Commercial Distribution

  • 30884908104241 ()
  • 00884908104240 ()
  • 50884908104245 ()
MR1903424S

  • Vascular catheter introduction needle

N/AN/A - 00884908104219

3F (1.1MM ID) X 3CM3F (1.1MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/20CM NITINOL WIREW/20CM NITINO & 24GA SAFETY NEEDLE
Medical Components, Inc.
MR1903224S
Not in Commercial Distribution

  • 50884908104214 ()
  • 30884908104210 ()
  • 00884908104219 ()
MR1903224S

  • Vascular catheter introduction needle

2F AND 3F VASCU-SHEATH TEARAWAY INTRODUCER2F AND 3F VASCU-SHEATH TEARAWAY INTROD - 00884908104165

2F (0.7MM ID) X 2CM2F (0.7MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/40CM NITINOL WIREW/40CM NITINO & 22GA SAFETY NEEDLE
Medical Components, Inc.
MR1902422S
Not in Commercial Distribution

  • 30884908104166 ()
  • 00884908104165 ()
  • 50884908104160 ()
MR1902422S

  • Vascular catheter introduction needle

N/AN/A - 00884908104158

2F (0.7MM ID) X 2CM2F (0.7MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/40CM NITINOL WIREW/40CM NITINO & 24GA SAFETY NEEDLE
Medical Components, Inc.
MR1902424S
Not in Commercial Distribution

  • 50884908104153 ()
  • 30884908104159 ()
  • 00884908104158 ()
MR1902424S

  • Vascular catheter introduction needle

N/AN/A - 00884908104080

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

Clear Guide CORE - B201CGCORE130

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

2F AND 3F VASCU-SHEATH TEARAWAY INTRODUCER2F AND 3F VASCU-SHEATH TEARAWAY INTROD - 00884908104288

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 AND 3F VASCU-SHEATH TEARAWAY INTRODUCER2F AND 3F VASCU-SHEATH TEARAWAY INTROD - 00884908104196

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 AND 3F VASCU-SHEATH TEARAWAY INTRODUCER2F AND 3F VASCU-SHEATH TEARAWAY INTROD - 00884908104189

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

2F AND 3F VASCU-SHEATH TEARAWAY INTRODUCER2F AND 3F VASCU-SHEATH TEARAWAY INTROD - 00884908104295

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

RAPID 20 E™ - 03573026588526

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

SG 101-D Reducing Adapter - M996SG101D0

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
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