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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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ENT Suction Tube #3 - G25010096030

A hand-held surgical instrument, formed in the shape of a tube, used to provide dissection while controlling intraoperative bleeding, and for the removal of debris/fluids, during ear/nose/throat (ENT) surgery. The device is connected to the tubing of a suction system at the proximal end and there is an opening at the working end through which the suction is applied to the site. The distal end is typically shaped as a rounded, flat blade, allowing the two functions to be applied simultaneously. It will have fingertip suction control and eliminates the need for a separate suction tip. It is made of metal and comes in various shapes and sizes. This is a reusable device.
N S SURGICAL COMPANY
10-096-03
In Commercial Distribution

  • G25010096030 ()

  • Length: 15 Centimeter
10-096-03

  • ENT suction dissector

ENT Suction Tube #2 - G25010096020

A hand-held surgical instrument, formed in the shape of a tube, used to provide dissection while controlling intraoperative bleeding, and for the removal of debris/fluids, during ear/nose/throat (ENT) surgery. The device is connected to the tubing of a suction system at the proximal end and there is an opening at the working end through which the suction is applied to the site. The distal end is typically shaped as a rounded, flat blade, allowing the two functions to be applied simultaneously. It will have fingertip suction control and eliminates the need for a separate suction tip. It is made of metal and comes in various shapes and sizes. This is a reusable device.
N S SURGICAL COMPANY
10-096-02
In Commercial Distribution

  • G25010096020 ()

  • Length: 15 Centimeter
10-096-02

  • ENT suction dissector

SuperBall 12 degrees Reverse - 00850000630031

The SuperBall™ Meniscal Repair System 12 Reverse is a single-patient and single-use device for repair procedures in the lateral and medial meniscus and for meniscal implant fixation. The SuperBall™ System is provided EtO sterile.
ARCURO MEDICAL LTD
A
In Commercial Distribution

  • 00850000630031 ()
SBD-SB-12-012

  • Polyester suture, non-bioabsorbable, multifilament

SuperBall 24 degrees Up - 00850000630024

The SuperBall™ Meniscal Repair System 24 Up is a single-patient and single-use device for repair procedures in the lateral and medial meniscus and for meniscal implant fixation. The SuperBall™ System is provided EtO sterile.
ARCURO MEDICAL LTD
A
In Commercial Distribution

  • 00850000630024 ()
SBD-SB-12-024

  • Polyester suture, non-bioabsorbable, multifilament

EndoSound® Ultrasound Disposable Kit (UDK-T) 5008 - 00850050934103

EndoSound Vision System (EVS) UDK-T is a disposable, single-use sterile kit that is used to attach the UTM to the compatible endoscope and provide transducer and needle articulation. Sleeve Size: Inner Diameter: 9.3mm Wall Thickness: 0.7mm
Endosound, Inc.
5008
In Commercial Distribution

  • 00850050934103 ()
  • 00850050934066 ()

  • Lumen/Inner Diameter: 9.3 Millimeter
  • .7mm wall thickness
5007

  • General-purpose ultrasound imaging system

EndoSound® Ultrasound Disposable Kit (UDK-T) 5010 - 00850050934097

EndoSound Vision System (EVS) UDK-T is a disposable, single-use sterile kit that is used to attach the UTM to the compatible endoscope and provide transducer and needle articulation. Sleeve Size: Inner Diameter: 9.5mm Wall Thickness: 1.25mm
Endosound, Inc.
5010
In Commercial Distribution

  • 00850050934097 ()
  • 00850050934059 ()

  • Lumen/Inner Diameter: 9.5 Millimeter
  • 1.25mm wall thickness
5009

  • General-purpose ultrasound imaging system

OviTex® - 00856072005654

The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cutting Template is intended to allow users to trace and cut specific shapes of implantable materials, such as the OviTex Reinforced Tissue Matrix.
TELA BIO, INC.
F10345-0610T
In Commercial Distribution

  • 00856072005654 ()

  • Length: 6 Centimeter
  • Width: 10 Centimeter


  • Surgical implant template, reusable

OviTex® - 00856072005647

The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cutting Template is intended to allow users to trace and cut specific shapes of implantable materials, such as the OviTex Reinforced Tissue Matrix.
TELA BIO, INC.
F10345-0608T
In Commercial Distribution

  • 00856072005647 ()

  • Length: 6 Centimeter
  • Width: 8 Centimeter


  • Surgical implant template, reusable

OviTex® - 00856072005630

The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cutting Template is intended to allow users to trace and cut specific shapes of implantable materials, such as the OviTex Reinforced Tissue Matrix.
TELA BIO, INC.
F10340-0608T
In Commercial Distribution

  • 00856072005630 ()

  • Length: 6 Centimeter
  • Width: 8 Centimeter


  • Surgical implant template, reusable

OviTex® - 00856072005623

The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cutting Template is intended to allow users to trace and cut specific shapes of implantable materials, such as the OviTex Reinforced Tissue Matrix.
TELA BIO, INC.
F10339-1012T
In Commercial Distribution

  • 00856072005623 ()

  • Length: 10 Centimeter
  • Width: 12 Centimeter


  • Surgical implant template, reusable
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