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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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Sterile Equipment Drape, AssistArm Surgical Drape, 7" X 96", Latex Free
SPECTRUM, INC.
982-03955-000
In Commercial Distribution

  • 10855495007365 ()
  • 00855495007368 ()
  • 20855495007362 ()
GCS-6920

  • Medical equipment/instrument drape, single-use
Sterile Equipment Drape, 12" X 100" w/Bag Clip, Latex Free
SPECTRUM, INC.
982-03954-001
Not in Commercial Distribution

  • 10855495007358 ()
  • 00855495007351 ()
SD-100

  • Medical equipment/instrument drape, single-use
Sterile Equipment Drape, ESS Universal Camera Drape, 7" X 96", Latex Free
SPECTRUM, INC.
982-03922-000
In Commercial Distribution

  • 10855495007341 ()
  • 00855495007344 ()
  • 20855495007348 ()
ESS-6920

  • Medical equipment/instrument drape, single-use
Sterile Equipment Drape, Josnoe Gama Probe Cover, 5" X 96", Latex Free
SPECTRUM, INC.
982-03891-000
In Commercial Distribution

  • 20855495007331 ()
  • 10855495007334 ()
  • 00855495007337 ()
JN-6000

  • Instrument/equipment drape, single-use, sterile
Sterile Equipment Drape, Tetra Mobile X-Ray Image Intensifier
SPECTRUM, INC.
982-03725-000
In Commercial Distribution

  • 20855495007324 ()
  • 10855495007327 ()
  • 00855495007320 ()
956925TET

  • Instrument/equipment drape, single-use, sterile
CAVUX Facet Fixation System (CAVUX FFS) is an integrated construct comprised of a CAVUX Cage and a single ALLY Bone Screw. CAVUX FFS is placed bilaterally through a posterior surgical approach and spans the interspace with points of fixation at each end of the construct. CAVUX FFS is intended for temporary stabilization as an adjunct to posterior cervical fusion in skeletally mature patients. CAVUX FFS is indicated for patients requiring a revision for an anterior pseudarthrosis at one level, from C3 to C7, with autogenous and/or allogenic bone graft.
Providence Medical Technology, Inc.
DX-31-404
In Commercial Distribution

  • 00852776006607 ()


  • Implantable cervical facet joint distractor
CAVUX Facet Fixation System (CAVUX FFS) is an integrated construct comprised of a CAVUX Cage and a single ALLY Bone Screw. CAVUX FFS is placed bilaterally through a posterior surgical approach and spans the interspace with points of fixation at each end of the construct. CAVUX FFS is intended for temporary stabilization as an adjunct to posterior cervical fusion in skeletally mature patients. CAVUX FFS is indicated for patients requiring a revision for an anterior pseudarthrosis at one level, from C3 to C7, with autogenous and/or allogenic bone graft.
Providence Medical Technology, Inc.
DX-31-403
In Commercial Distribution

  • 00852776006591 ()


  • Implantable cervical facet joint distractor
Warming Earplugs
KOBAYASHI CONSUMER PRODUCTS, LLC
667560800138
In Commercial Distribution

  • 10667560800135 ()
  • 00667560800138 ()
  • 10667560800203 ()


  • Earplugs, reusable
Oil Emulsion Dressing 5" x 9"
Dukal LLC
224
In Commercial Distribution

  • 10665973017775 ()
  • 00665973017778 ()
  • 20665973017772 ()
224

  • Petrolatum woven gauze pad
Plain Packing Strip 1/4" x 5 yd
Dukal LLC
260
In Commercial Distribution

  • 00665973017259 ()
  • 20665973017253 ()
  • 10665973017256 ()
260

  • Gauze strip, non-antimicrobial
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