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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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Monfilament Mesh
SURGICAL INNOVATION ASSOCIATES, INC.
PTM2025
In Commercial Distribution

  • 00860000875943 ()
PTM2025

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Monfilament Mesh
SURGICAL INNOVATION ASSOCIATES, INC.
PTM0616
In Commercial Distribution

  • 00860000875929 ()
PTM0616

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Monfilament Mesh
SURGICAL INNOVATION ASSOCIATES, INC.
PTM1025
In Commercial Distribution

  • 00860000875905 ()
PTM1025

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Spice Up Plain Male Condom
SPICE UP ENTERTAINMENT LLC
SU8793
In Commercial Distribution

  • 20860000864804 ()
  • 10860000864807 ()
  • 00860000864800 ()


  • Basic male condom, Hevea-latex
A device that is applied to the tip of a contact type tonometer in order to avoid cross-infection between patients. The device is made of plastic. This is a single-use device.
AUTOMATED OPHTHALMICS, INC.
AO316
In Commercial Distribution

  • 00860000603805 ()


  • Ophthalmic tonometer tip cover
Topical Skin Adhesive Flex with Tips
TISSUE SEAL L.L.C.
1051260-P
In Commercial Distribution

  • 10860000589038 ()
  • 00860000589031 ()

  • Total Volume: 0.5 Milliliter


  • Dermal surgical adhesive/sealant applicator
  • Skin-approximation adhesive
Topical Skin Adhesive Clear
TISSUE SEAL L.L.C.
TS1050071-FP
In Commercial Distribution

  • 10860000589021 ()
  • 00860000589024 ()

  • Total Volume: 0.5 Milliliter
TS1050071-FP

  • Skin-approximation adhesive
Topical Skin Adhesive Blue
TISSUE SEAL L.L.C.
TS1050044-FP
In Commercial Distribution

  • 00860000589000 ()
  • 10860000589007 ()

  • Total Volume: 0.5 Milliliter
TS1050044-FP

  • Skin-approximation adhesive
PTFE Non-absorbable Suture 30 inch in length, USP 5/0, Taper Point Needle, 13mm, 1/2 curvature, double armed, Sterile
Golnit Sutures
FTD501324d-75
In Commercial Distribution

  • 00860000584098 ()
  • 00860000584081 ()

  • 13mm 1/2 Circle Taper Point Needle
  • Length: 30 Inch
  • USP 5/0 Suture Thread


  • Polyolefin/fluoropolymer suture, multifilament
Sterile GuideBlade
Ambitus Medical Supplies LLC
AMB 1746
In Commercial Distribution

  • 00860000561907 ()
  • 10860000561904 ()
  • 20860000561901 ()
  • 30860000561908 ()
AMB 1746-10

  • Scalpel, single-use
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