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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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Superelastic Nitinol Implant Style A 9 x 8 x 8mm
FUSION ORTHOPEDICS, LLC
DB-09-0808-A
In Commercial Distribution

  • 00819034023332 ()
DB-09-0808-A

  • Orthopaedic bone staple, non-adjustable, non-sterile
AO LCKG EVANS BONE SEG 22 X 22 X 8
Paragon 28, Inc.
AOLEW-22-8
In Commercial Distribution

  • 00889795120625 ()
AOLEW-22-8

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
AO LCKG EVANS BONE SEG 22 X 22 X 10
Paragon 28, Inc.
AOLEW-22-10
In Commercial Distribution

  • 00889795120618 ()
AOLEW-22-10

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
AO LCKG EVANS BONE SEG 20 X 20 X 8
Paragon 28, Inc.
AOLEW-20-8
In Commercial Distribution

  • 00889795120601 ()
AOLEW-20-8

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Control Box 272.0(W) x 203.0(D) x 67.4(H)
Saeshin Precision Co., Ltd.
TRAUS XIP10
In Commercial Distribution

  • 08809260470163 ()


  • Dental power tool system, line-powered
22mm L x 10mm W x 15mm H; Calix-PLIF, PC
Xtant Medical Holdings, Inc.
X034-0180PC-STR
In Commercial Distribution

  • M697X0340180PCSTR1 ()

  • Height: 15 Millimeter
  • Width: 10 Millimeter
  • Length: 22 Millimeter


  • Polymeric spinal fusion cage, sterile
22mm L x 10mm W x 14mm H; Calix-PLIF, PC
Xtant Medical Holdings, Inc.
X034-0179PC-STR
In Commercial Distribution

  • M697X0340179PCSTR1 ()

  • Height: 14 Millimeter
  • Width: 10 Millimeter
  • Length: 22 Millimeter


  • Polymeric spinal fusion cage, sterile
Equipment Cover Bag Type 20” x 12” (51cm x 30cm)
ARGON MEDICAL DEVICES, INC.
396223
In Commercial Distribution

  • 20886333212587 ()
  • 00886333212583 ()

  • 20” x 12” (51cm x 30cm)
396223

  • Instrument/equipment drape, single-use, sterile
Equipment Cover Bag Type 30” x 17” (76cm x 43cm)
ARGON MEDICAL DEVICES, INC.
396222
In Commercial Distribution

  • 20886333212570 ()
  • 00886333212576 ()

  • 30” x 17” (76cm x 43cm)
396222

  • Instrument/equipment drape, single-use, sterile
Equipment Cover Bag Type 36” x 20” (91cm x 51cm)
ARGON MEDICAL DEVICES, INC.
396221
In Commercial Distribution

  • 20886333212563 ()
  • 00886333212569 ()

  • 36” x 20” (91cm x 51cm)
396221

  • Instrument/equipment drape, single-use, sterile
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