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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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BioPatch™ Antimicrobial Dressing with Chlorhexidine Gluconate is a hydrophillic polyurethane absorptive foam with Chlorhexidine Gluconate (CHG) which inhibits bacterial growth under the dressing. The dressing is intended to be used to absorb exudate, cover a wound caused by vascular and nonvascular percutaneous medical devices during surgery, as well as reduce local infection and colonization of microorganisms.
Integra Lifesciences Corporation
3151
In Commercial Distribution

  • 30705031004348 ()
  • 20705031004341 ()
  • 10705031004344 ()
  • H20631513 ()

  • 0.75in (1.9cm) circumfrence; 1.5mm center hole


  • Exudate-absorbent dressing, non-gel, antimicrobial
BioPatch™ Antimicrobial Dressing with Chlorhexidine Gluconate is a hydrophillic polyurethane absorptive foam with Chlorhexidine Gluconate (CHG) which inhibits bacterial growth under the dressing. The dressing is intended to be used to absorb exudate, cover a wound caused by vascular and nonvascular percutaneous medical devices during surgery, as well as reduce local infection and colonization of microorganisms.
Integra Lifesciences Corporation
3150
In Commercial Distribution

  • 30705031004331 ()
  • 20705031004334 ()
  • 10705031004337 ()
  • H20631503 ()

  • 1in (2.5cm) circumference 4mm center hole


  • Exudate-absorbent dressing, non-gel, antimicrobial
The subjected screw is part of the zLOCK Lumbar Facet Fixation System. The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components: 1) a Facet Screw with a washer and 2) a Modular spacer. The system including a dedicated tool set.
ZYGOFIX LTD
1
In Commercial Distribution

  • 07290019421245 ()
ZFS-40SC-25TU

  • Spinal bone screw, non-bioabsorbable
The subjected screw is part of the zLOCK Lumbar Facet Fixation System. The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components: 1) a Facet Screw with a washer and 2) a Modular spacer. The system including a dedicated tool set.
ZYGOFIX LTD
1
Not in Commercial Distribution

  • 07290019421238 ()
ZF-40FS-20TU

  • Spinal bone screw, non-bioabsorbable
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.
MGT89010PPT
In Commercial Distribution

  • 10381780119890 ()
  • M268MGT89010PPT1 ()

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

  • 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.
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.
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 MEBO Wound Dressing is a C060 gamma-adiation sterilized dressing consisting of sesame oi, beeswax and fabric dressing, which provides a moist environment for optimal wound healing
Mebo Life Science Inc.
60mm x 120mm
In Commercial Distribution

  • 00860005367535 ()


  • Wound-nonadherent dressing, absorbent, non-antimicrobial
The MEBO Wound Dressing is a CO60 gamma-radiation sterilized dressing consisting of sesame oil, beeswax and fabric dressing, which provides a moist environment for optimal wound healing.
Mebo Life Science Inc.
35mmx160mm
In Commercial Distribution

  • 00860005367528 ()
  • 10860005367525 ()


  • Wound-nonadherent dressing, absorbent, non-antimicrobial
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