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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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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
1523215
Not in Commercial Distribution

  • 30381780121972 ()
  • 10381780121978 ()
  • M26915232151 ()

  • 24kHz Ultrasonic Frequency


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
CUSA® Selector® 24kHz Neuro Short Sterile Tip Set
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1523211
Not in Commercial Distribution

  • 10381780121961 ()
  • M26915232111 ()

  • 24kHz Ultrasonic Frequency


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
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
The Integra Movement Great Toe System total arthroplasty is an anatomically designed, semi-constrained, two-piece device designed for resurfacing of the base of the 1st metatarso-phalangeal (MTP) joint. The device uses the metatarsal hemi arthroplasty device paired with a phalangeal base manufactured from titanium with a UHMWPE articulating surface insert. The phalangeal joint replacement device is intended for cemented use.
Ascension Orthopedics, Inc.
MGT89040PPT
In Commercial Distribution

  • 10381780119920 ()
  • M268MGT89040PPT1 ()

  • .771 in L x .549 in W x .472 in H; Size 40
MGT89040PPT

  • Partial metatarsophalangeal joint prosthesis
The Integra Movement Great Toe System total arthroplasty is an anatomically designed, semi-constrained, two-piece device designed for resurfacing of the base of the 1st metatarso-phalangeal (MTP) joint. The device uses the metatarsal hemi arthroplasty device paired with a phalangeal base manufactured from titanium with a UHMWPE articulating surface insert. The phalangeal joint replacement device is intended for cemented use.
Ascension Orthopedics, Inc.
MGT89030PPT
In Commercial Distribution

  • 10381780119913 ()
  • M268MGT89030PPT1 ()

  • .721 in L x .520 in W x .433 in H; Size 30
MGT89030PPT

  • Partial metatarsophalangeal joint prosthesis
The Integra Movement Great Toe System total arthroplasty is an anatomically designed, semi-constrained, two-piece device designed for resurfacing of the base of the 1st metatarso-phalangeal (MTP) joint. The device uses the metatarsal hemi arthroplasty device paired with a phalangeal base manufactured from titanium with a UHMWPE articulating surface insert. The phalangeal joint replacement device is intended for cemented use.
Ascension Orthopedics, Inc.
MGT89020PPT
In Commercial Distribution

  • 10381780119906 ()
  • M268MGT89020PPT1 ()

  • .660 in L x .492 in W x .394 in H; Size 20
MGT89020PPT

  • Partial metatarsophalangeal joint prosthesis
The Integra Movement Great Toe System total arthroplasty is an anatomically designed, semi-constrained, two-piece device designed for resurfacing of the base of the 1st metatarso-phalangeal (MTP) joint. The device uses the metatarsal hemi arthroplasty device paired with a phalangeal base manufactured from titanium with a UHMWPE articulating surface insert. The phalangeal joint replacement device is intended for cemented use.
Ascension Orthopedics, Inc.
MGT89010PPT
In Commercial Distribution

  • 10381780119890 ()
  • M268MGT89010PPT1 ()

  • .606 in L x .463 in W x .354 in H; Size 10
MGT89010PPT

  • Partial metatarsophalangeal joint prosthesis
PriMatrix® Ag Fenestrated 20 x 25 cm
TEI BIOSCIENCES INC.
607-104-225
In Commercial Distribution

  • 10381780113782 ()

  • 20 x 25 x (0.20 - 1.04) cm x cm x mm


  • Animal-derived wound matrix dressing
PriMatrix® Ag Fenestrated 10 x 25 cm
TEI BIOSCIENCES INC.
607-104-125
In Commercial Distribution

  • 10381780113775 ()

  • 10 x 25 x (0.20 - 1.04) cm x cm x mm


  • Animal-derived wound matrix dressing
PriMatrix® Ag Fenestrated 8 x 12 cm
TEI BIOSCIENCES INC.
607-104-812
In Commercial Distribution

  • 10381780113768 ()

  • 8 x 12 x (0.20 - 1.04) cm x cm x mm


  • Animal-derived wound matrix dressing
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