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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Fenestrated Facet Screw Cannulated (Hex holding type) D5.5 x 20
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039824200 ()
FA.FC.5520

  • Bone-screw internal spinal fixation system, non-sterile
Fenestrated Facet Screw Cannulated (Hex holding type) D5 x 20
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039824101 ()
FA.FC.5020

  • Bone-screw internal spinal fixation system, non-sterile
Threaded Facet Screw Cannulated (Hex holding type) D5 x 20
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039823845 ()
FA.TC.5020

  • Bone-screw internal spinal fixation system, non-sterile
CUSA® Selector® 24KHz Standard Flue (Pack of 20)
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1523042
Not in Commercial Distribution

  • M27315230421 ()
  • 10381780040668 ()
  • 00381780040661 ()

  • 24kHz Ultrasonic Frequency
1523042

  • Ultrasonic surgical system flue
Integra® CUSA NXT™
INTEGRA LIFESCIENCES (IRELAND) LIMITED
NXT3220EA
Not in Commercial Distribution

  • 10381780039495 ()
  • M269NXT3220EA1 ()


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
The CUSA NXT Bone Tips are accessories to the CUSA NXT Ultrasonic Surgical Aspirator System that is 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 and Thoracoscopic surgery.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
NXT3220
Not in Commercial Distribution

  • 30381780039482 ()
  • 10381780039488 ()
  • M269NXT322011 ()


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
Integra® CUSA NXT™
INTEGRA LIFESCIENCES (IRELAND) LIMITED
NXT3219EA
Not in Commercial Distribution

  • 10381780039471 ()
  • M269NXT3219EA1 ()


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
The CUSA NXT Bone Tips are accessories to the CUSA NXT Ultrasonic Surgical Aspirator System that is 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 and Thoracoscopic surgery.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
NXT3219
Not in Commercial Distribution

  • 30381780039468 ()
  • 10381780039464 ()
  • M269NXT321919 ()


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
Integra® CUSA NXT™
INTEGRA LIFESCIENCES (IRELAND) LIMITED
NXT3218EA
Not in Commercial Distribution

  • M269NXT3218EA1 ()
  • 10381780039457 ()


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
The CUSA NXT Bone Tips are accessories to the CUSA NXT Ultrasonic Surgical Aspirator System that is 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 and Thoracoscopic surgery.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
NXT3218
Not in Commercial Distribution

  • 30381780039444 ()
  • 10381780039440 ()
  • M269NXT321818 ()


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