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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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Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL syringe is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen. It is a viscous solution of purified natural Sodium Hylauronate (Hyalectin®) in buffered physiological sodium chloride. The sodium hylauronate is extracted from rooster combs. It is given by intra-articular injection in a treatment cycle consisting of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly cycles.
FIDIA FARMACEUTICI SPA
89122-0724-20
In Commercial Distribution

  • M713891220724200 ()
89122-0724-20

  • Synovial fluid supplementation medium
The STROPP (Single Tunnel Repair of Plantar Plate) System is a sterile packaged kit that include PEEK implants and related instruments for plantar plate repair. Implants are packaged with the following manual surgical instruments for general use: a needle, needle passer, suture passer, an inserter, K-wires and distractor. The implants are compatible with Size 0 suture; suture is not included with the system. The STROPP System is intended for use with a suture in metatarsal ligament and tendon repairs.
CROSSROADS EXTREMITY SYSTEMS
1601-0001
In Commercial Distribution

  • 00815432023264 ()

  • 3.0mm Diameter x 8.0mm Length
1601-0001

  • Suturing needle holder, single-use
  • Suturing needle holder, reusable
  • Orthopaedic surgical distractor, internal
  • Tendon/ligament bone anchor, non-bioabsorbable
  • Bone-resection orthopaedic reamer, reprocessed
  • Bone-resection orthopaedic reamer, single-use
  • Orthopaedic bone wire
  • Orthopaedic inorganic implant inserter/extractor, reusable
  • Suturing unit, single-use
  • Suturing needle, single-use
The STROPP (Single Tunnel Repair of Plantar Plate) System is a sterile packaged kit that include PEEK implants and related instruments for plantar plate repair. Implants are packaged with the following manual surgical instruments for general use: a needle, needle passer, suture passer, an inserter, K-wires and distractor. The implants are compatible with Size 0 suture; suture is not included with the system. The STROPP System is intended for use with a suture in metatarsal ligament and tendon repairs.
CROSSROADS EXTREMITY SYSTEMS
STRoPP Plantar Plate Repair Kit - Sterile
In Commercial Distribution

  • 00815432023097 ()

  • 3.0mm Diameter x 8.0mm Length
1601-0000

  • Suturing needle holder, single-use
  • Suturing needle holder, reusable
  • Orthopaedic surgical distractor, internal
  • Tendon/ligament bone anchor, non-bioabsorbable
  • Bone-resection orthopaedic reamer, reprocessed
  • Bone-resection orthopaedic reamer, single-use
  • Orthopaedic bone wire
  • Orthopaedic inorganic implant inserter/extractor, reusable
  • Suturing unit, single-use
  • Suturing needle, single-use
RAPIDSORB IPS STERILITY SHIELD
Synthes GmbH
530.554
In Commercial Distribution

  • H9805305540 ()
  • 10887587057279 ()
530554

  • Craniofacial bone tack, bioabsorbable
  • Surgical power tool battery-exchange sterility cover
The DTRAX Cervical Cage-T is a single-use, titanium alloy intervertebral implant available in various footprints and heights. It is intended to be used in cervical spinal fusion surgery for skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level.
Providence Medical Technology, Inc.
PD-31-100
Not in Commercial Distribution

  • 10852776006017 ()
PD-31-100

  • Implantable cervical facet joint distractor
The DTRAX Cervical Cage-B is a single-use, titanium alloy intervertebral implant available in various footprints and heights. It is intended to be used in cervical spinal fusion surgery for skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level.
Providence Medical Technology, Inc.
PD-31-200
Not in Commercial Distribution

  • 10852776006000 ()
PD-31-200

  • Implantable cervical facet joint distractor
PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
PG1225
In Commercial Distribution

  • 00085412818658 ()
PG1225

  • Cardiovascular patch, animal-derived
VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. VASCU-GUARD is terminally sterilized using gamma irradiation. and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG02515
In Commercial Distribution

  • 00085412818634 ()
VG02515

  • Cardiovascular patch, animal-derived
PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
PG1016
In Commercial Distribution

  • 00085412818610 ()
PG1016

  • Cardiovascular patch, animal-derived
PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
PG0814
In Commercial Distribution

  • 00085412818597 ()
PG0814

  • Cardiovascular patch, animal-derived
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