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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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Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sqin. Microlyte® Matrix is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.
IMBED BIOSCIENCES, INC.
91007
In Commercial Distribution

  • 00850019162035 ()


  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
Surgaflex™ is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sq in. Surgaflex™ is intended for the management of wounds. The device is packaged in sterile, sealed boxes of 5.
IMBED BIOSCIENCES, INC.
91017
In Commercial Distribution

  • 00850019162288 ()


  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sqin. Microlyte® Matrix is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.
IMBED BIOSCIENCES, INC.
91006
In Commercial Distribution

  • 00850019162011 ()


  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
Only use the CUSA Selector wrench set to tighten and loosen tips and extensions on the handpiece. Always secure the handle of the handpiece in the holder provided. Never assemble or disassemble the handpiece by holding the handle in your hand as damage may occur to the handpiece. The CUSA Selector Wrench Set is intended for use with Standard handpieces.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1523072M1
In Commercial Distribution

  • 10381780040392 ()


  • Ultrasonic surgical system torque wrench, 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
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
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
The KGTI metatarsal implant is spherical and extends from the plantar base of the metatarsal head dorsally. The implant is fixed by means of a stem, which is inserted into the metatarsal intramedullary canal. The implant is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.
Ascension Orthopedics, Inc.
012007
Not in Commercial Distribution

  • M2480120071 ()
  • 10381780065449 ()

  • .93 in L x .759 in W; Size 3
012007

  • Partial metatarsophalangeal joint prosthesis
The KGTI metatarsal implant is spherical and extends from the plantar base of the metatarsal head dorsally. The implant is fixed by means of a stem, which is inserted into the metatarsal intramedullary canal. The implant is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.
Ascension Orthopedics, Inc.
012006
Not in Commercial Distribution

  • M2480120061 ()
  • 10381780065432 ()

  • .93 in L x .759 in W; Size 3
012006

  • Partial metatarsophalangeal joint prosthesis
The KGTI metatarsal implant is spherical and extends from the plantar base of the metatarsal head dorsally. The implant is fixed by means of a stem, which is inserted into the metatarsal intramedullary canal. The implant is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.
Ascension Orthopedics, Inc.
012005
Not in Commercial Distribution

  • M2480120051 ()
  • 10381780065425 ()

  • .89 in L x .733 in W; Size 2
012005

  • Partial metatarsophalangeal joint prosthesis
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