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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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Vitale Silicone Foam Dressings with Antibacterial Silver, 4"x4", 10/box, 10 boxes/case, 4 cases/overpack
CELLERA LLC
20044
In Commercial Distribution

  • B492200442 ()
  • B492200441 ()
  • B492200440 ()
  • B492200443 ()
20044

  • Exudate-absorbent dressing, non-gel, antimicrobial
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
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
The Proximal Phalanx Total Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL89040PPT
In Commercial Distribution

  • M269TRL89040PPT1 ()
  • 10381780236955 ()

  • Size 40; .771 in L x .549 in W (head); .472 in L (stem)


  • Surgical implant template, reusable
The Proximal Phalanx Total Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL89030PPT
In Commercial Distribution

  • M269TRL89030PPT1 ()
  • 10381780236924 ()

  • Size 30; .721 in L x .520 in W (head); .433 in L (stem)


  • Surgical implant template, reusable
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