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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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Axiom® Mills Sump Atraum™ With ClotStop® - M665111167AT0

Dual Lumen, Mediastinal, Round, Silicone, Open Tip, With ClotStop®
AXIOM MEDICAL, INCORPORATED
111167AT
In Commercial Distribution

  • M665111167AT3 ()
  • M665111167AT1 ()
  • M665111167AT0 ()

  • Catheter Gauge: 18 French


  • Sump drain

Axiom® - M665111140SC0

Thoracic Catheter, Right Angle, Silicone, With Scale, Double Pouched
AXIOM MEDICAL, INCORPORATED
111140SC
In Commercial Distribution

  • M665111140SC3 ()
  • M665111140SC1 ()
  • M665111140SC0 ()

  • 40 FR


  • Pleural catheter

Axiom® Atraum™ With ClotStop® - M665111140ATSC0

Thoracic Catheter, Right Angle, Silicone, With Scale, Double Pouched, With ClotStop®
AXIOM MEDICAL, INCORPORATED
111140ATSC
In Commercial Distribution

  • M665111140ATSC3 ()
  • M665111140ATSC1 ()
  • M665111140ATSC0 ()

  • 40 FR


  • Pleural catheter

Axiom® - M6651111400

Thoracic Catheter, Right Angle, Silicone
AXIOM MEDICAL, INCORPORATED
111140
In Commercial Distribution

  • M6651111403 ()
  • M6651111401 ()
  • M6651111400 ()

  • 40 FR


  • Pleural catheter

Axiom® - M665111136SC0

Thoracic Catheter, Right Angle, Silicone, With Scale, Double Pouched
AXIOM MEDICAL, INCORPORATED
111136SC
In Commercial Distribution

  • M665111136SC3 ()
  • M665111136SC1 ()
  • M665111136SC0 ()

  • 36 FR


  • Pleural catheter

Axiom® - M665111136S0

Thoracic Catheter, Right Angle, Silicone, With Scale
AXIOM MEDICAL, INCORPORATED
111136S
In Commercial Distribution

  • M665111136S3 ()
  • M665111136S1 ()
  • M665111136S0 ()

  • 36 FR


  • Pleural catheter

Axiom® Atraum™ With ClotStop® - M665111136ATSP0

Thoracic Catheter, Right Angle, Silicone, Double Pouched, With ClotStop®
AXIOM MEDICAL, INCORPORATED
111136ATSP
In Commercial Distribution

  • M665111136ATSP1 ()
  • M665111136ATSP0 ()
  • M665111136ATSP3 ()

  • 36 FR


  • Pleural catheter

Axiom® Atraum™ With ClotStop® - M665111136ATSC0

Thoracic Catheter, Right Angle, Silicone, With Scale, Double Pouched, With ClotStop®
AXIOM MEDICAL, INCORPORATED
111136ATSC
In Commercial Distribution

  • M665111136ATSC3 ()
  • M665111136ATSC1 ()
  • M665111136ATSC0 ()

  • 36 FR


  • Pleural catheter

Axiom® Atraum™ With ClotStop® - M665111136ATS0

Thoracic Catheter, Right Angle, Silicone, With Scale, With ClotStop®
AXIOM MEDICAL, INCORPORATED
111136ATS
In Commercial Distribution

  • M665111136ATS3 ()
  • M665111136ATS1 ()
  • M665111136ATS0 ()

  • 36 FR


  • Pleural catheter

Axiom® Atraum™ With ClotStop® - M665111136AT0

Thoracic Catheter, Right Angle, Silicone, With ClotStop®
AXIOM MEDICAL, INCORPORATED
111136AT
In Commercial Distribution

  • M665111136AT3 ()
  • M665111136AT1 ()
  • M665111136AT0 ()

  • 36 FR


  • Pleural catheter

Axiom® - M6651111360

Thoracic Catheter, Right Angle, Silicone
AXIOM MEDICAL, INCORPORATED
111136
In Commercial Distribution

  • M6651111363 ()
  • M6651111361 ()
  • M6651111360 ()

  • 36 FR


  • Pleural catheter

Axiom® - M665111132SC0

Thoracic Catheter, Right Angle, Silicone, With Scale, Double Pouched
AXIOM MEDICAL, INCORPORATED
111132SC
In Commercial Distribution

  • M665111132SC3 ()
  • M665111132SC1 ()
  • M665111132SC0 ()

  • 32 FR


  • Pleural catheter

Axiom® - M665111132S0

Thoracic Catheter, Right Angle, Silicone, With Scale
AXIOM MEDICAL, INCORPORATED
111132S
In Commercial Distribution

  • M665111132S3 ()
  • M665111132S1 ()
  • M665111132S0 ()

  • 32 FR


  • Pleural catheter

Sutralon - M583N1040611

10-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 6 inch (15 cm) / Needle Specifications: ST-140-6, Spatula Tip, 3/8 (140 degrees), length 6.00 mm, wire 0.15 mm / # of needles: Single Arm
VISIONARY MEDICAL SUPPLIES INC
N104061
In Commercial Distribution

  • M583N1040613 ()
  • M583N1040612 ()
  • M583N1040611 ()

  • Angle: 140 degree
  • 10-0 USP
  • Outer Diameter: 0.15 Millimeter
  • Length: 6.00 Millimeter
  • Length: 15 Centimeter


  • Nylon suture, non-bioabsorbable, monofilament

Sutrazorb - M583A84082TP1

8-0 Suture USP / Thread Specifications: PGA, 5 inch (13 cm) / Needle Specifications: TP-140-8, Taper Point, 3/8 (140 degrees), length 6.5mm, wire diameter 0.20 mm / # of needles: Double arm
VISIONARY MEDICAL SUPPLIES INC
A84082TP
In Commercial Distribution

  • M583A84082TP3 ()
  • M583A84082TP2 ()
  • M583A84082TP1 ()

  • Outer Diameter: 0.20 Millimeter
  • Angle: 140 degree
  • Length: 6.5 Millimeter
  • Length: 13 Centimeter
  • 8-0 USP


  • Polyglycolic acid suture

Sutrazorb - M583A740921

7-0 Suture USP / Thread Specifications: PGA, 18 inch (45 cm) / Needle Specifications: ST-140-9, Spatula Tip, 3/8 (140 degrees), length 6.5 mm, wire 0.23 mm / # of needles: Double arm
VISIONARY MEDICAL SUPPLIES INC
A74092
In Commercial Distribution

  • M583A740921 ()
  • M583A740923 ()
  • M583A740922 ()

  • Angle: 140 degree
  • 7-0 USP
  • Outer Diameter: 0.23 Millimeter
  • Length: 45 Centimeter
  • Length: 6.5 Millimeter


  • Polyglycolic acid suture

Sutrazorb - M583A690921

6-0 Suture USP / Thread Specifications: PGA, 18 inch (45 cm) / Needle Specifications: ST-90-9, Spatula Tip, 1/4 (90 degrees), length 8.0mm, wire diameter 0.23 mm / # of needles: Double arm
VISIONARY MEDICAL SUPPLIES INC
A69092
In Commercial Distribution

  • M583A690921 ()
  • M583A690923 ()
  • M583A690922 ()

  • 6-0 USP
  • Length: 8.0 Millimeter
  • Angle: 90 degree
  • Outer Diameter: 0.23 Millimeter
  • Length: 45 Centimeter


  • Polyglycolic acid suture

Sutrazorb - M583A660921

6-0 Suture USP / Thread Specifications: PGA, 18 inch (45 cm) / Needle Specifications: ST-160-9, Spatula Tip, 1/2 (160 degrees), length 8.0 mm, wire 0.23 mm / # of needles: Double arm
VISIONARY MEDICAL SUPPLIES INC
A66092
In Commercial Distribution

  • M583A660923 ()
  • M583A660922 ()
  • M583A660921 ()

  • Outer Diameter: 0.23 Millimeter
  • Angle: 160 degree
  • Length: 8.0 Millimeter
  • Length: 45 Centimeter
  • 6-0 USP


  • Polyglycolic acid suture

ResQCPR System - M5921208250001

The ResQCPR system contains two ResQPODs and one ResQPump
ADVANCED CIRCULATORY SYSTEMS INC
12-0825-000
In Commercial Distribution

  • M5921208220000 ()
  • M5921208250001 ()
  • M5921208230001 ()


  • Cardiac resuscitator, manual

ResQPOD ITD 10 - M5921202420000

The ResQPOD ITD 10 is indicated for the temporary increase in blood circulation.
ADVANCED CIRCULATORY SYSTEMS INC
12-0242-000
In Commercial Distribution

  • M5921202420000 ()
  • M5921202420001 ()
  • M5921202420002 ()


  • Cardiopulmonary resuscitation impedance valve, inspiratory

Sutrasilk - M583VS840821

8-0 Suture USP / Thread Specifications: Silk, Virgin, 16 inch (40 cm) / Needle Specifications: ST-140-8, Spatula tip, 3/8 circle (140 degrees), length 6.0 mm, wire 0.20mm / # of needles: double arm
VISIONARY MEDICAL SUPPLIES INC
VS84082
In Commercial Distribution

  • M583VS840823 ()
  • M583VS840822 ()
  • M583VS840821 ()

  • Angle: 140 degree
  • 8-0 USP
  • Outer Diameter: 0.20 Millimeter
  • Length: 6.0 Millimeter
  • Length: 40 Centimeter


  • Silk suture

Sutrasilk - M583VS840811

8-0 Suture USP / Thread Specifications: Silk, Virgin, 16 inch (40 cm) / Needle Specifications: ST-140-8, Spatula tip, 3/8 circle (140 degrees), length 6.0 mm, wire 0.20mm / # of needles: single arm
VISIONARY MEDICAL SUPPLIES INC
VS84081
In Commercial Distribution

  • M583VS840813 ()
  • M583VS840812 ()
  • M583VS840811 ()

  • Length: 40 Centimeter
  • Length: 6.0 Millimeter
  • Outer Diameter: 0.20 Millimeter
  • 8-0 USP
  • Angle: 140 degree


  • Silk suture

Sutrasilk - M583S74092TP1

7-0 Suture USP / Thread Specifications: Silk, Black Braided, 18 inch (45 cm) / Needle Specifications: TP-140-9, Taper Point, 3/8 circle (140 degrees), length 9.0 mm, wire 0.23mm / # of needles: Double arm
VISIONARY MEDICAL SUPPLIES INC
S74092TP
In Commercial Distribution

  • M583S74092TP3 ()
  • M583S74092TP2 ()
  • M583S74092TP1 ()

  • Angle: 140 degree
  • 7-0 USP
  • Outer Diameter: 0.23 Millimeter
  • Length: 9.0 Millimeter
  • Length: 45 Centimeter


  • Silk suture

Sutrasilk - M583S740921

7-0 Suture USP / Thread Specifications: Silk, Black Braided, 18 inch (45 cm) / Needle Specifications: ST-140-9, Spatula Tip, 3/8 circle (140 degrees), length 6.6 mm, wire 0.23mm / # of needles: Double arm
VISIONARY MEDICAL SUPPLIES INC
S74092
In Commercial Distribution

  • M583S740923 ()
  • M583S740922 ()
  • M583S740921 ()

  • Angle: 140 degree
  • Length: 45 Centimeter
  • Length: 6.6 Millimeter
  • Outer Diameter: 0.23 Millimeter
  • 7-0 USP


  • Silk suture

Sutrasilk - M583S6401121

6-0 Suture USP / Thread Specifications: Silk, Black Braided, 30 inch (76 cm) / Needle Specifications: ST-140-11, Spatula Tip, 3/8 circle (140 degrees), length 8.0 mm, wire 0.28mm / # of needles: Double arm
VISIONARY MEDICAL SUPPLIES INC
S640112
In Commercial Distribution

  • M583S6401123 ()
  • M583S6401122 ()
  • M583S6401121 ()

  • Angle: 140 degree
  • 6-0 USP
  • Outer Diameter: 0.28 Millimeter
  • Length: 8.0 Millimeter
  • Length: 76 Centimeter


  • Silk suture

Sutrasilk - M583S440171C1

4-0 Suture USP / Thread Specifications: Silk, Black Braided, 30 inch (76 cm) / Needle Specifications: CT-135-17, Cutting Tip, 3/8 circle (140 degrees), length 15.9 mm, wire 0.43mm / # of needles: Single arm
VISIONARY MEDICAL SUPPLIES INC
S440171C
In Commercial Distribution

  • M583S440171C3 ()
  • M583S440171C2 ()
  • M583S440171C1 ()

  • Angle: 140 degree
  • 4-0 USP
  • Outer Diameter: 0.43 Millimeter
  • Length: 15.9 Millimeter
  • Length: 76 Centimeter


  • Silk suture

Sutralene - M583P990621

9-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 12 inch (30 cm) / Needle Specifications: ST-90-6, Spatula Tip, ¼ circle (90 degrees), length 16 mm, wire 0.15 mm / # of needles: Double arm
VISIONARY MEDICAL SUPPLIES INC
P99062
In Commercial Distribution

  • M583P990623 ()
  • M583P990622 ()
  • M583P990621 ()

  • Angle: 90 degree
  • 9-0 USP
  • Outer Diameter: 0.15 Millimeter
  • Length: 16 Millimeter
  • Length: 30 Centimeter


  • Polyolefin/fluoropolymer suture, monofilament

Sutralene - M583P90090621

9-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 12 inch (30 cm) / Needle Specifications: ST-000-6, Spatula Tip, straight (0 degrees), length 16 mm, wire 0.15 mm AND Needle Specifications: ST-90-6, Spatula Tip, 1/4 circle (90 degrees), length 16 mm, wire 0.15 mm / # of needles: Double arm
VISIONARY MEDICAL SUPPLIES INC
P9009062
In Commercial Distribution

  • M583P90090623 ()
  • M583P90090622 ()
  • M583P90090621 ()

  • Angle: 90 degree
  • Angle: 0 degree
  • 9-0 USP
  • Outer Diameter: 0.15 Millimeter
  • Length: 16 Millimeter
  • Length: 30 Centimeter


  • Polyolefin/fluoropolymer suture, monofilament

Sutralene - M583P9006221

9-0 Suture USP / Thread Specifications: Polypropylene, Monofilament, 5 cm / Needle Specifications: ST-000-6, Spatula Tip, straight (0 degrees), length 16 mm, wire 0.15 mm Double armed
VISIONARY MEDICAL SUPPLIES INC
P90062-2
In Commercial Distribution

  • M583P9006223 ()
  • M583P9006222 ()
  • M583P9006221 ()

  • Length: 5 Centimeter
  • Length: 16 Millimeter
  • Outer Diameter: 0.15 Millimeter
  • 9-0 USP
  • Angle: 0 degree
  • Angle: 160 degree


  • Polyolefin/fluoropolymer suture, monofilament

Sutralene - M583P900621

9-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 8 inch (20 cm) / Needle Specifications: ST-000-6, Spatula Tip, straight (0 degrees), length 16 mm, wire 0.15 mm / # of needles: Double arm
VISIONARY MEDICAL SUPPLIES INC
P90062
In Commercial Distribution

  • M583P900623 ()
  • M583P900622 ()
  • M583P900621 ()

  • Angle: 0 degree
  • 9-0 USP
  • Outer Diameter: 0.15 Millimeter
  • Length: 16 Millimeter
  • Length: 30 Centimeter


  • Polyolefin/fluoropolymer suture, monofilament

Sutralene - M583P90060621

9-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 12 inch (30 cm) / Needle Specifications: ST-000-6, Spatula Tip, straight (0 degrees), length 16 mm, wire 0.15 mm AND Needle Specifications: ST-160-6, Spatula Tip, ½ circle (160 degrees), length 6.2 mm, wire 0.15 mm / # of needles: Double arm
VISIONARY MEDICAL SUPPLIES INC
P9006062
In Commercial Distribution

  • M583P90060623 ()
  • M583P90060622 ()
  • M583P90060621 ()

  • Angle: 160 degree
  • Angle: 0 degree
  • 9-0 USP
  • Outer Diameter: 0.15 Millimeter
  • Length: 6.2 Millimeter
  • Length: 16 Millimeter
  • Length: 30 Centimeter


  • Polyolefin/fluoropolymer suture, monofilament

Sutralene - M583P540151RC1

5-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 28 inch (70 cm) / Needle Specifications: RC-130-15, Reverse Cutting, 3/8 circle (140 degrees), length 13.1 mm, wire 0.38 mm / # of needles: single arm
VISIONARY MEDICAL SUPPLIES INC
P540151RC
In Commercial Distribution

  • M583P540151RC3 ()
  • M583P540151RC2 ()
  • M583P540151RC1 ()

  • Angle: 140 degree
  • 5-0 USP
  • Outer Diameter: 0.38 Millimeter
  • Length: 13.1 Millimeter
  • Length: 70 Centimeter


  • Polyolefin/fluoropolymer suture, monofilament

Sutralene - M583P109062TP1

10-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 8 inch (20 cm) / Needle Specifications: TP-90-6, Taper Point, ¼ circle (90 degrees), length 13 mm, wire 0.15 mm / # of needles: Double arm
VISIONARY MEDICAL SUPPLIES INC
P109062TP
In Commercial Distribution

  • M583P109062TP3 ()
  • M583P109062TP2 ()
  • M583P109062TP1 ()

  • Angle: 0 degree
  • 10-0 USP
  • Outer Diameter: 0.15 Millimeter
  • Length: 13 Millimeter
  • Length: 30 Centimeter


  • Polyolefin/fluoropolymer suture, monofilament

Sutralene - M583P1000621

10-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 8 inch (20 cm) / Needle Specifications: ST-000-6, Spatula Tip, straight (0 degrees), length 16 mm, wire 0.15 mm / # of needles: Double arm
VISIONARY MEDICAL SUPPLIES INC
P100062
In Commercial Distribution

  • M583P1000623 ()
  • M583P1000622 ()
  • M583P1000621 ()

  • Angle: 0 degree
  • 10-0 USP
  • Outer Diameter: 0.15 Millimeter
  • Length: 16 Millimeter
  • Length: 20 Centimeter


  • Polyolefin/fluoropolymer suture, monofilament

Sutralon - M583N960621

10-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 12 inch (30 cm) / Needle Specifications: ST-160-6, Spatula Tip, 1/2 (160 degrees), length 5.60 mm, wire 0.15 mm / # of needles: Double Arm
VISIONARY MEDICAL SUPPLIES INC
N96062
In Commercial Distribution

  • M583N960623 ()
  • M583N960622 ()
  • M583N960621 ()

  • Angle: 160 degree
  • 9-0 USP
  • Outer Diameter: 0.15 Millimeter
  • Length: 5.60 Millimeter
  • Length: 30 Centimeter


  • Nylon suture, non-bioabsorbable, monofilament

Sutralon - M583N960611

10-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 12 inch (30 cm) / Needle Specifications: ST-160-6, Spatula Tip, 1/2 (160 degrees), length 5.60 mm, wire 0.15 mm / # of needles: Single Arm
VISIONARY MEDICAL SUPPLIES INC
N96061
In Commercial Distribution

  • M583N960613 ()
  • M583N960612 ()
  • M583N960611 ()

  • Length: 30 Centimeter
  • Length: 5.60 Millimeter
  • Outer Diameter: 0.15 Millimeter
  • 9-0 USP
  • Angle: 160 degree


  • Nylon suture, non-bioabsorbable, monofilament

Sutralon - M583N940821

9-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 16 inch (40 cm) / Needle Specifications: ST-140-8, Spatula Tip, 3/8 (140 degrees), length 6.00 mm, wire 0.20 mm / # of needles: Double Arm
VISIONARY MEDICAL SUPPLIES INC
N94082
In Commercial Distribution

  • M583N940823 ()
  • M583N940822 ()
  • M583N940821 ()

  • Angle: 140 degree
  • 9-0 USP
  • Outer Diameter: 0.20 Millimeter
  • Length: 6.00 Millimeter
  • Length: 40 Centimeter


  • Nylon suture, non-bioabsorbable, monofilament

Sutralon - M583N940811

9-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 16 inch (40 cm) / Needle Specifications: ST-140-8, Spatula Tip, 3/8 (140 degrees), length 6.00 mm, wire 0.20 mm / # of needles: Single Arm
VISIONARY MEDICAL SUPPLIES INC
N94081
In Commercial Distribution

  • M583N940813 ()
  • M583N940812 ()
  • M583N940811 ()

  • Length: 40 Centimeter
  • Length: 6.00 Millimeter
  • Outer Diameter: 0.20 Millimeter
  • 9-0 USP
  • Angle: 140 degree


  • Nylon suture, non-bioabsorbable, monofilament

Sutralon - M583N940621

9-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 12 inch (30 cm) / Needle Specifications: ST-140-6, Spatula Tip, 3/8 (140 degrees), length 6.00 mm, wire 0.15 mm / # of needles: Double Arm
VISIONARY MEDICAL SUPPLIES INC
N94062
In Commercial Distribution

  • M583N940623 ()
  • M583N940622 ()
  • M583N940621 ()

  • Angle: 140 degree
  • 9-0 USP
  • Outer Diameter: 0.15 Millimeter
  • Length: 6.00 Millimeter
  • Length: 30 Centimeter


  • Nylon suture, non-bioabsorbable, monofilament

Sutralon - M583N940611

9-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 15cm / Needle Specifications: ST-140-6, Spatula Tip, 3/8 (140 degrees), length 6.00 mm, wire 0.15 mm / # of needles: Single Arm
VISIONARY MEDICAL SUPPLIES INC
N94061
In Commercial Distribution

  • M583N940613 ()
  • M583N940612 ()
  • M583N940611 ()

  • Length: 15 Centimeter
  • Length: 6.00 Millimeter
  • Outer Diameter: 0.15 Millimeter
  • 9-0 USP
  • Angle: 140 degree


  • Nylon suture, non-bioabsorbable, monofilament
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