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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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osteo-WEDGE 2.5mm x 22mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Gramedica
GM-200-22
In Commercial Distribution

  • M621OW25LBS22MM0 ()

  • 2.5mm x 22mm
OW2.5LBS-22MM

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
osteo-WEDGE 2.5mm x 20mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Gramedica
GM-200-20
In Commercial Distribution

  • M621OW25LBS20MM0 ()

  • 2.5mm x 20mm
OW2.5LBS-20MM

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
osteo-WEDGE 2.5mm x 18mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Gramedica
GM-200-18
In Commercial Distribution

  • M621OW25LBS18MM0 ()

  • 2.5mm x 18mm
OW2.5LBS-18MM

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
osteo-WEDGE 2.5mm x 16mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Gramedica
GM-200-16
In Commercial Distribution

  • M621OW25LBS16MM0 ()

  • 2.5mm x 16mm
OW2.5LBS-16MM

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
osteo-WEDGE 2.5mm x 14mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Gramedica
GM-200-14
In Commercial Distribution

  • M621OW25LBS14MM0 ()

  • 2.5mm x 14mm
OW2.5LBS-14MM

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
osteo-WEDGE 2.5mm x 12mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Gramedica
GM-200-12
In Commercial Distribution

  • M621OW25LBS12MM0 ()

  • 2.5mm x 12mm
OW2.5LBS-12MM

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
osteo-WEDGE 2.5mm x 10mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Gramedica
GM-200-10
In Commercial Distribution

  • M621OW25LBS10MM0 ()

  • 2.5mm x 10mm
OW2.5LBS-10MM

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
osmed self-inflating tissue expanders are made of a specially developed hydrogel (methylmethacrylate-n-vinylpyrrolidone-co-polymer) using the osmotic principle to expand physiological tissue space due to the absorption of body fluid from the surrounding tissues. The osmed Sphere Expanders are used for expansion of the orbita at congenital anophthalmia and microphthalmia.
Osmed GmbH
5.0ml
In Commercial Distribution

  • EOSM35275001 ()
352-7500

  • Skin-port tissue expander
osmed self-inflating tissue expanders are made of a specially developed hydrogel (methylmethacrylate-n-vinylpyrrolidone-co-polymer) using the osmotic principle to expand physiological tissue space due to the absorption of body fluid from the surrounding tissues. The osmed Sphere Expanders are used for expansion of the orbita at congenital anophthalmia and microphthalmia.
Osmed GmbH
4.0ml
In Commercial Distribution

  • EOSM35274001 ()
352-7400

  • Skin-port tissue expander
osmed self-inflating tissue expanders are made of a specially developed hydrogel (methylmethacrylate-n-vinylpyrrolidone-co-polymer) using the osmotic principle to expand physiological tissue space due to the absorption of body fluid from the surrounding tissues. The osmed Sphere Expanders are used for expansion of the orbita at congenital anophthalmia and microphthalmia.
Osmed GmbH
3.0ml
In Commercial Distribution

  • EOSM35273001 ()
352-7300

  • Skin-port tissue expander
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