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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 Pedicle Screw Spinal Fixation Systemconsists of a variety of shapes and sizes of rods, screws, and cross links which can be rigidly locked into a variety of configurations, made for the individual case.
BM KOREA CO., LTD
A1P1-5545
In Commercial Distribution

  • 08809255540611 ()

  • Length: 45 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
The Pedicle Screw Spinal Fixation Systemconsists of a variety of shapes and sizes of rods, screws, and cross links which can be rigidly locked into a variety of configurations, made for the individual case.
BM KOREA CO., LTD
A1P1-5540
In Commercial Distribution

  • 08809255540604 ()

  • Length: 40 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
The Pedicle Screw Spinal Fixation Systemconsists of a variety of shapes and sizes of rods, screws, and cross links which can be rigidly locked into a variety of configurations, made for the individual case.
BM KOREA CO., LTD
A1P1-5535
In Commercial Distribution

  • 08809255540598 ()

  • Length: 35 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
The Pedicle Screw Spinal Fixation Systemconsists of a variety of shapes and sizes of rods, screws, and cross links which can be rigidly locked into a variety of configurations, made for the individual case.
BM KOREA CO., LTD
A1P1-5530
In Commercial Distribution

  • 08809255540581 ()

  • Length: 30 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
The Pedicle Screw Spinal Fixation Systemconsists of a variety of shapes and sizes of rods, screws, and cross links which can be rigidly locked into a variety of configurations, made for the individual case.
BM KOREA CO., LTD
A1P1-4540
In Commercial Distribution

  • 08809255540574 ()

  • Length: 40 Millimeter
  • Outer Diameter: 4.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
The Pedicle Screw Spinal Fixation Systemconsists of a variety of shapes and sizes of rods, screws, and cross links which can be rigidly locked into a variety of configurations, made for the individual case.
BM KOREA CO., LTD
A1P1-4535
In Commercial Distribution

  • 08809255540567 ()

  • Length: 35 Millimeter
  • Outer Diameter: 4.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
The Pedicle Screw Spinal Fixation Systemconsists of a variety of shapes and sizes of rods, screws, and cross links which can be rigidly locked into a variety of configurations, made for the individual case.
BM KOREA CO., LTD
A1P1-4530
In Commercial Distribution

  • 08809255540550 ()

  • Length: 30 Millimeter
  • Outer Diameter: 4.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
The Pedicle Screw Spinal Fixation Systemconsists of a variety of shapes and sizes of rods, screws, and cross links which can be rigidly locked into a variety of configurations, made for the individual case.
BM KOREA CO., LTD
A1P1-4525
In Commercial Distribution

  • 08809255540543 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 25 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Kit Contains: (T0E15-F) E-Series FlipTop™ Cassette - Fixed Rack 15 with Standard Divider (R166) Explorer 5 (R245) Mirror Handle (Cone-Socket) (R283) IPC- Non Coated (R286) G2 Thin Composite (R287) G3 Thin Composite (R363S) 113 Straight Serrated Cord Packer (R375) Mixing Spatula/Applicator (R386) 38-39 Excavator (T040) Tweezers COLLEGE (T046) Articulating Paper Forceps MILLER (T050) #5 Mirror (15/16") (T235) Aspirating Anesthetic Syringe Medium (T319) Bur Block (T800) IRIS Scissors, curved
PDT, INC.
R984 Composite & Crown Prep Kit
In Commercial Distribution

  • 00813677024503 ()
R984

  • Suture scissors
  • Dental surgical probe, reusable
  • Instrument tray, reusable
  • Dental spatula, reusable
  • Dental mirror, reusable
  • Manual non-rotary dental instrument handle
  • Dental restoration carver, amalgam, reusable
  • Gingival retraction cord packing tool
  • Dental irrigation/aspiration syringe
  • Dental excavator, reusable
  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
The Ascension® PyroHemiSphereTM is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.
Ascension Orthopedics, Inc.
PYROHEMIINSP
Not in Commercial Distribution

  • M268PYROHEMIINSP1 ()
  • 10381780235033 ()

  • 12.9 in L x 8.4 in W x 2.3 in H


  • General external orthopaedic fixation system implantation kit, reusable
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