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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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CUSA® Selector® 24KHz Saber Tip™
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1523216
Not in Commercial Distribution

  • 30381780177672 ()
  • 10381780177678 ()
  • M26915232161 ()

  • 24KHz Ultrasonic Frequency
1523216

  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
Integrator™ Chiropractic Adjustment Instrument - Tips Only, Gray - 100 Pack
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
015-99613
Not in Commercial Distribution

  • H834015996131 ()
  • 10381780168997 ()
  • 00381780168990 ()
015-99613

  • Joint/spinal manipulator, mechanical
Integrator™ Chiropractic Adjustment Instrument - Tips Only, White - 100 Pack
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
015-99612
Not in Commercial Distribution

  • H834015996121 ()
  • 10381780168980 ()
  • 00381780168983 ()
015-99612

  • Joint/spinal manipulator, mechanical
Integrator™ Chiropractic Adjustment Instrument
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
015-99603
Not in Commercial Distribution

  • H834015996030 ()
  • 10381780168966 ()
015-99603

  • Joint/spinal manipulator, mechanical
Chiropractic Mallet
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
015-99600
Not in Commercial Distribution

  • H834015996000 ()
  • 10381780168959 ()
015-99600

  • Joint/spinal manipulator, mechanical
SICAT OPTIMOTION
SiCAT GmbH & Co. KG
10501
In Commercial Distribution

  • D776105010 ()
10501

  • Custom-made mouthguard
KGTI™ Instrument Set (01-5000)
Ascension Orthopedics, Inc.
KGTISET
Not in Commercial Distribution

  • M248KGTISET1 ()
  • 10381780257264 ()


  • Partial metatarsophalangeal joint prosthesis
The extended life laparoscopic tip is intended for use with the CUSA® Excel/ CUSA® Excel+ Ultrasonic Surgical Aspirator System, CUSA® Handpiece and accessories. The CUSA Excel System is indicated for use in these surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue is desirable: • 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
C4604ELTUS
In Commercial Distribution

  • 30381780248242 ()
  • 10381780248248 ()
  • M269C4604ELTUS1 ()

  • Length 30.14 cm; Diameter 1.98mm


  • Soft-tissue ultrasonic surgical system handpiece tip, reusable
CUSA® Selector® 24kHz Laparascopic Flue (Pack of 10)
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1523032
Not in Commercial Distribution

  • M27315230321 ()
  • 10381780040682 ()
  • 00381780040685 ()

  • 24kHz Ultrasonic Frequency
1523032

  • Ultrasonic surgical system flue
CUSA® Selector® 35KHzStandard Flue (Pack of 20)
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1523043
Not in Commercial Distribution

  • M27315230431 ()
  • 10381780040675 ()
  • 00381780040678 ()

  • 35kHz Ultrasonic Frequency
1523043

  • Ultrasonic surgical system flue
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