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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 Sensilift is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick Skin Types I-IV.
EL GLOBAL TRADE LTD
ST100US04SNS
In Commercial Distribution

  • 05060445341255 ()


  • Radio-frequency skin surface treatment system
The sensiLift is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick Skin Types I-IV.
EL GLOBAL TRADE LTD
ST100US01SNS
In Commercial Distribution

  • 05060445341125 ()


  • Radio-frequency skin surface treatment system
The TargetScan needles are used in conjunction with the biopsy planning feature of the Targetscan System to target the prostate biopsy locations created in a biopsy plan.
Best Nomos
015-A200
In Commercial Distribution

  • 00852656007441 ()


  • Prostate biopsy needle
SubQ It! Bioabsorbable Skin Closure System consists of a single-patient use, disposable stapler preloaded with 10 bioabsorbable fasteners, packaged and sterilized individually in a protective foil pouch.
OPUS KSD, INC.
404010
In Commercial Distribution

  • 00867469000206 ()
  • 10867469000203 ()


  • Skin stapler
The Trabectome I/A Console (110V) is an aspiration pump intended for use in general surgery applications where aspiration of irrigation waste and waste fluid is desired.
NEOMEDIX CORPORATION
550014
In Commercial Distribution

  • 00854028002023 ()
550014-01

  • Ophthalmic irrigation/aspiration pump
MERIFLUOR Cryptosporidium/Giardia (MERIFLUOR C/G) is an in vitro direct immunofluorescent detection procedure for the simultaneous detection of Cryptosporidium oocysts and Giardia cysts in fecal material.
MERIDIAN BIOSCIENCE, INC.
250050
In Commercial Distribution

  • 00840733101113 ()
250050

  • Multiple faecal parasite antigen IVD, kit, direct fluorescent test (DFT)
Batlle ICL manipulator, 4 3/4'', vaulted shaft, 12.0mm from bend to tip, round roughened spatula tip, for easy placement of lens under the iris, round handle
AMBLER SURGICAL CORP.
Batlle ICL manipulator
In Commercial Distribution

  • 00190660101169 ()
9421E

  • Ocular hook/spatula/manipulator, reusable
The TriMAX Impant System is a Nitinol Superelastic bone staple for use in surgery of the hand and foot for bone fragment osteotomy fixation and joint arthrodesis.
CROSSROADS EXTREMITY SYSTEMS
TriMAX 25mm Full Prep Kit
In Commercial Distribution

  • 00815432027613 ()
7300-2500KT

  • Intraoperative bone pin/screw, non-sterile
  • Intraoperative orthopaedic bone pin/screw, single-use
  • Bone-resection orthopaedic reamer, single-use
  • Bone-resection orthopaedic reamer, reprocessed
  • Orthopaedic inorganic implant inserter/extractor, single-use
  • Orthopaedic inorganic implant inserter/extractor, reusable
  • Surgical drill guide, single-use
  • Surgical drill guide, reusable
  • Orthopaedic broach
  • Orthopaedic implant aiming/guiding block, single-use
  • Orthopaedic implant aiming/guiding block, reusable
  • Orthopaedic implant impactor, reusable
The TriMAX Impant System is a Nitinol Superelastic bone staple for use in surgery of the hand and foot for bone fragment osteotomy fixation and joint arthrodesis.
CROSSROADS EXTREMITY SYSTEMS
TriMAX 20mm Full Prep Kit
In Commercial Distribution

  • 00815432027606 ()
7300-2000KT

  • Intraoperative bone pin/screw, non-sterile
  • Intraoperative orthopaedic bone pin/screw, single-use
  • Bone-resection orthopaedic reamer, single-use
  • Bone-resection orthopaedic reamer, reprocessed
  • Orthopaedic inorganic implant inserter/extractor, single-use
  • Orthopaedic inorganic implant inserter/extractor, reusable
  • Surgical drill guide, single-use
  • Surgical drill guide, reusable
  • Orthopaedic broach
  • Orthopaedic implant aiming/guiding block, single-use
  • Orthopaedic implant aiming/guiding block, reusable
  • Orthopaedic implant impactor, reusable
The TriMAX Implant System is a Nitinol Superelastic bone staple for use in surgery of the hand and foot for bone fragment osteotomy fixation and joint arthrodesis.
CROSSROADS EXTREMITY SYSTEMS
TriMAX 18mm Full Prep Kit
In Commercial Distribution

  • 00815432027590 ()

  • 20mm x 20mm x 20mm
7300-1800KT

  • Intraoperative bone pin/screw, non-sterile
  • Intraoperative orthopaedic bone pin/screw, single-use
  • Bone-resection orthopaedic reamer, single-use
  • Bone-resection orthopaedic reamer, reprocessed
  • Orthopaedic implant aiming/guiding block, reusable
  • Orthopaedic implant aiming/guiding block, single-use
  • Orthopaedic broach
  • Orthopaedic inorganic implant inserter/extractor, single-use
  • Orthopaedic inorganic implant inserter/extractor, reusable
  • Surgical drill guide, reusable
  • Surgical drill guide, single-use
  • Orthopaedic implant impactor, reusable
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