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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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This is a medical device.
KaVo Dental GmbH
1.005.8949
In Commercial Distribution

  • EKAV100589490 ()
scaler Tip No 5 A

  • Ultrasonic dental scaling/debridement system
Thin Osteotome Blade, 8mm X 5”
SYMMETRY MEDICAL INC.
11-009-000
In Commercial Distribution

  • 00847538001136 ()
00-9986-021-27

  • Orthopaedic osteotome
Thin Osteotome Blade, 10mm X 5”
SYMMETRY MEDICAL INC.
11-008-000
In Commercial Distribution

  • 00847538001129 ()
00-9986-021-26

  • Orthopaedic osteotome
No Description
Manus Medical, LLC
AVID334
In Commercial Distribution

  • 20811870033869 ()
  • 00811870033865 ()


  • Surgical towel
No Description
The Atlanta Dental Supply Company
MFS5SS
In Commercial Distribution

  • 00371347002584 ()
  • 10371347002581 ()


  • Dental mirror, reusable
No Description
The Atlanta Dental Supply Company
MFS5CS
In Commercial Distribution

  • 00371347002577 ()
  • 10371347002574 ()


  • Dental mirror, reusable
No Description
Trilliant Surgical, LLC
300-50-008
In Commercial Distribution

  • 00812926025346 ()

  • Custom 5 Hole VLC Gridlock Plate


  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Element intended to become part of an assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.
GEXFIX SA
1010-1054
In Commercial Distribution

  • 07640136270132 ()


  • External orthopaedic fixation system, single-use
Element intended to become part of an assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.
GEXFIX SA
1010-1024
In Commercial Distribution

  • 07640136270033 ()


  • External orthopaedic fixation system, single-use
Cone Trial, Size 5, 24 degrees
TOTAL JOINT ORTHOPEDICS, INC.
2022.05.024
In Commercial Distribution

  • 00810094692063 ()

  • Size 5, 24 degrees


  • Knee femur prosthesis trial, reusable
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