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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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Bloodborne Pathogens Protection
Adventure Ready Brands
1
In Commercial Distribution

  • 00814471010785 ()
9999-2313

  • Non-organic haemostatic agent
WOUND FREE Resorbable Collagen Wound Dressing Pads. 2"x2". Sterile.
APPLIED DENTAL, INC.
CWD-0505
In Commercial Distribution

  • 10814639025924 ()
  • 00814639025927 ()
  • 20814639025921 ()
CWD-0505

  • Collagen wound matrix dressing
Ultrasonic Shears with Advanced Hemostasis
STRYKER SUSTAINABILITY SOLUTIONS, INC.
N/A
In Commercial Distribution

  • 37613327346252 ()
  • 07613327346251 ()

  • Diameter: 5.0 Millimeter
  • Length: 36.0 Centimeter
HARH36

  • Soft-tissue ultrasonic surgical system holder/tip, reprocessed
Ultrasonic Scalpel Shears with Advanced Hemostasis
STRYKER SUSTAINABILITY SOLUTIONS, INC.
N/A
In Commercial Distribution

  • 37613327346238 ()
  • 07613327346237 ()

  • Length: 23.0 Centimeter
  • Diameter: 5.0 Millimeter
HARH23

  • Soft-tissue ultrasonic surgical system holder/tip, reprocessed
The Tips are machined hollow tubes with fittings at the distal end which connect to the handpiece. They are manufactured from titanium alloy. The Tips deliver the mechanical motion to ablate the tissues then aspirate the waste fluid and suspended tissue pieces. The Flues are hollow cones. The Flues are intended to direct the saline irrigation fluid to the site of operation. They are manufactured from clear plastic.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1523235
Not in Commercial Distribution

  • 30381780040365 ()
  • 10381780040361 ()
  • M26915232351 ()

  • 35kHz Ultrasonic Frequency


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
CUSA® NXT Selector Tubing
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1517079
Not in Commercial Distribution

  • 30381780040297 ()
  • 10381780040293 ()
  • M26915170791 ()
1517079

  • Surgical irrigation/aspiration tubing set
MRI Tubing Kit Extension:The Selector tubing connects the handpiece to the IV fluid and connects the handpiece to the suction canister on the CUSA® Selector / CUSA NXT console.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1532024
Not in Commercial Distribution

  • 30381780040259 ()
  • 10381780040255 ()
  • M26915320241 ()


  • Surgical irrigation/aspiration tubing set
Microsurgical - Box Of 10: The Selector tubing connects the handpiece to the IV fluid and connects the handpiece to the suction canister on the CUSA® Selector / CUSA NXT console.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1529036
Not in Commercial Distribution

  • 30381780040242 ()
  • 10381780040248 ()
  • M26915290361 ()


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
Integra® CUSA NXT™ 35 KHz Extended Length Tip
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1523243EA
Not in Commercial Distribution

  • 10381780039518 ()
  • M6101523243EA1 ()

  • 35kHz Ultrasonic Frequency


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
The CUSA NXT Extended Length Tip for soft tissue is an accessory to the CUSA NXT and CUSA Selector Ultrasonic Surgical Aspirator Systems that are indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable, including Neurosurgery/Gastrointestinal and affiliated organ surgery/Urological surgery/Plastic and Reconstructive surgery/General surgery/Orthopedic surgery/Gynecological surgery/Thoracic surgery/Laparoscopic surgery/Thoracoscopic surgery.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1523243
Not in Commercial Distribution

  • M610152324315 ()
  • 10381780039501 ()
  • 00381780039504 ()

  • 35kHz Ultrasonic Frequency


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
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