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® 35kHz Neuro Sterile Tip Set
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1523231
Not in Commercial Distribution

  • 10381780121954 ()
  • M26915232311 ()

  • 35kHz Ultrasonic Frequency


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
SELECTOR HANDPIECE STERILIZATION TRAY:The steriliser tray provides a convenient handling system for sterilisation of re-usable devices.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
07289
In Commercial Distribution

  • 10381780121947 ()


  • Device sterilization/disinfection container, reusable
Selector Wrench Set : The Selector Wrench Set consists of a stainless steel holder and spanner, connected by a chain. The Wrench set is used to assemble the handpiece and tip, and to change tips in the sterile field. The Wrench Set is also used to disassemble the handpiece for cleaning and sterilization. The cut-outs in the holder are sized according to its use with specific handpieces.The wrench sets are required to ensure the tips are attached to the hand pieces correctly.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1523072M3
In Commercial Distribution

  • 10381780040415 ()


  • Ultrasonic surgical system torque wrench, single-use
Selector Wrench Set : The Selector Wrench Set consists of a stainless steel holder and spanner, connected by a chain. The Wrench set is used to assemble the handpiece and tip, and to change tips in the sterile field. The Wrench Set is also used to disassemble the handpiece for cleaning and sterilization. The cut-outs in the holder are sized according to its use with specific handpieces.The wrench sets are required to ensure the tips are attached to the hand pieces correctly.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1523072M2
Not in Commercial Distribution

  • 10381780040408 ()


  • Ultrasonic surgical system torque wrench, single-use
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
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
1523225
Not in Commercial Distribution

  • 30381780025539 ()
  • 10381780025535 ()
  • M26915232251 ()

  • 24kHz Ultrasonic Frequency


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
TISSUE EXPANDER, ROUND, SMOOTH
PMT CORPORATION
3612-75
In Commercial Distribution

  • 00650551142317 ()

  • Projection 10 Centimeter
  • Total Volume: 2500 Centiliter
  • Diameter 20 Centimeter
3612-75

  • Skin-port tissue expander
4"X4", 3Ply, 200 Pc(s)/Bag, 20 Bags/Case, 4000 Pc(s)/Case
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534850141 ()
  • 00683534850145 ()
NG-4403-3

  • Non-woven gauze pad
Integra® MESHED BILAYER WOUND MATRIX 8 in*10 in (20 cm*25 cm)
Integra Lifesciences Corporation
MWM8101
In Commercial Distribution

  • M269MWM81011 ()
  • 10381780032397 ()

  • Length: 25 Centimeter
  • Length: 10 Inch
  • Width: 8 Inch
  • Width: 20 Centimeter
MWM8101

  • Animal-derived wound matrix dressing
INTEGRA® BILAYER MATRIX WOUND DRESSING 8 in*10 in (20 cm*25 cm)
Integra Lifesciences Corporation
BMW8101
In Commercial Distribution

  • M269BMW81011 ()
  • 10381780032236 ()

  • Length: 25 Centimeter
  • Width: 20 Centimeter
  • Width: 8 Inch
  • Length: 10 Inch
BMW8101

  • Animal-derived wound matrix dressing
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