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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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(2) Eagle Screw-in Suture Anchor - 4.5mm (2) Eagle Knotless Suture Anchor - 4.75mm (1) Eagle Drill Guide (1) Eagle Drill 3.5mm (1) Eagle Drill 3.8mm (1) Eagle Tap 4.5mm
RESPONSIVE ORTHOPEDICS LLC
913000-4500
In Commercial Distribution

  • 00811714035925 ()
913000-4500

  • Tendon/ligament bone anchor, non-bioabsorbable
  • Fluted surgical drill bit, single-use
  • Surgical drill guide, single-use
  • Bone tap, single-use
The TAC PIN is a self tapping threaded wire. Its proximal part is fixed on a standard surgical power tool equipment and once the threaded wire is introduced and positioned as required, the surgeon cuts the protruding part at the bone surface. This pin is designed with a variable pitch, for a true and adapted compression. It is made out of titanium alloy, and it is delivered non sterile.
NEWDEAL
120025ND
Not in Commercial Distribution

  • M248120025ND1 ()
  • 10381780052845 ()

  • 1.6mm diam. x 25mm length
120025ND

  • Orthopaedic bone pin, non-bioabsorbable
The TAC PIN is a self tapping threaded wire. Its proximal part is fixed on a standard surgical power tool equipment and once the threaded wire is introduced and positioned as required, the surgeon cuts the protruding part at the bone surface. This pin is designed with a variable pitch, for a true and adapted compression. It is made out of titanium alloy, and it is delivered non sterile.
NEWDEAL
120020ND
Not in Commercial Distribution

  • 10381780052838 ()
  • M248120020ND1 ()

  • 1.6mm diam. x 20mm length
120020ND

  • Orthopaedic bone pin, non-bioabsorbable
The TAC PIN is a self tapping threaded wire. Its proximal part is fixed on a standard surgical power tool equipment and once the threaded wire is introduced and positioned as required, the surgeon cuts the protruding part at the bone surface. This pin is designed with a variable pitch, for a true and adapted compression. It is made out of titanium alloy, and it is delivered non sterile.
NEWDEAL
120015ND
Not in Commercial Distribution

  • M248120015ND1 ()
  • 10381780052821 ()

  • 1.6mm diam. x 15mm length
120015ND

  • Orthopaedic bone pin, non-bioabsorbable
No Description
Acuitive Technologies, Inc.
70-810-5524
In Commercial Distribution

  • 00810027270887 ()


  • Tendon/ligament bone anchor, bioabsorbable
  • Surgical drill guide, single-use
  • Fluted surgical drill bit, single-use
  • Orthopaedic inorganic implant inserter/extractor, single-use
No Description
Acuitive Technologies, Inc.
70-810-4524
In Commercial Distribution

  • 00810027270870 ()


  • Tendon/ligament bone anchor, bioabsorbable
  • Surgical drill guide, single-use
  • Fluted surgical drill bit, single-use
  • Orthopaedic inorganic implant inserter/extractor, single-use
No Description
Acuitive Technologies, Inc.
70-810-3515
In Commercial Distribution

  • 00810027270863 ()


  • Tendon/ligament bone anchor, bioabsorbable
  • Surgical drill guide, single-use
  • Fluted surgical drill bit, single-use
  • Orthopaedic inorganic implant inserter/extractor, single-use
No Description
Acuitive Technologies, Inc.
70-810-2912
In Commercial Distribution

  • 00810027270856 ()


  • Tendon/ligament bone anchor, bioabsorbable
  • Surgical drill guide, single-use
  • Fluted surgical drill bit, single-use
  • Orthopaedic inorganic implant inserter/extractor, single-use
The Raindrop Near Vision Inlay is a biocompatible hydrogel corneal inlay. It is designed to be implanted under a femtosecond laser flap onto the stromal bed of the cornea, centered over a light-constricted pupil. The Raindrop Near Vision Inlay reshapes the central region of the cornea to provide a zone of increased power for focusing on near objects, resulting in improvement in near vision. The Raindrop Near Vision Inlay is supplied steam sterilized and pre-loaded in its delivery device, the Inlay Inserter. It is for single-use only.
REVISION OPTICS, INC.
RD1-1
In Commercial Distribution

  • 10850394006013 ()
  • 20850394006010 ()

  • Diameter
RD1-1

  • Corneal inlay, aperture reducing
The ATOZ Expander Kit is a procedure kit used for orthodontic treatment and consists of an expander, screws, drivers, wires, and accessories. ATOZ Expander:MKE-08-F*1ea ATOZ Key: MK Key-L*1ea, MK Key-S*1ea ATOZ Mini-Screw: MKS-1611*8ea ATOZ Screwdriver MKD-S *1ea, MKD-L*1ea ATOZ Tooth connecting arms: MK Wire arm-1240*4ea
MK Meditech Inc.
ATOZ Expander Kit
In Commercial Distribution

  • 08800197900341 ()


  • Surgical screwdriver, reusable
  • Orthodontic archwire
  • Orthodontic anchoring screw
  • Orthodontic palate expander/teeth aligner, bonded
  • Orthodontic palate expander screw key
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