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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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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
1010-1053
In Commercial Distribution

  • 07640136270125 ()


  • 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
1010-1052
In Commercial Distribution

  • 07640136270118 ()


  • 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
1010-1026
In Commercial Distribution

  • 07640136270040 ()


  • External orthopaedic fixation system, single-use
Oval Pessary is used to treat uterine prolapse.
MEDGYN PRODUCTS, INC.
Pessary Oval w/support # 9
In Commercial Distribution

  • M803050119 ()
050119

  • Pelvic-organ-supporting pessary
Cube Pessary is used treat uterine prolapse.
MEDGYN PRODUCTS, INC.
Pessary Cube w/drain # 9
In Commercial Distribution

  • M803050075 ()
050075

  • Pelvic-organ-supporting pessary
Pessary ring is used to treat uterine prolapse.
MEDGYN PRODUCTS, INC.
Pessary Ring w/support #9
In Commercial Distribution

  • M803050034 ()
050034

  • Pelvic-organ-supporting pessary
No Description
Bonebridge AG
B-240100
In Commercial Distribution

  • 07640187462173 ()


  • Orthopaedic fixation plate, non-bioabsorbable
No Description
KATALYST SURGICAL LLC
N076-080
In Commercial Distribution

  • 00840096203868 ()


  • Periosteal elevator, reusable
No Description
FOURNITURES HOSPITALIERES INDUSTRIE
239562
In Commercial Distribution

  • 03661489395628 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
FOURNITURES HOSPITALIERES INDUSTRIE
201772
In Commercial Distribution

  • 03661489017728 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Content: 2 pieces Height: 16 mm Highly translucent zirconia for single crowns to large bridges (fully anatomic structures or reduced structures for veneering with ceramics)
ZIRKONZAHN SRL
ZRAD0502
In Commercial Distribution

  • D800ZRAD0502 ()


  • Dental bridge, ceramic
Content: 2 pieces Height: 22 mm Translucent zirconia for single crowns to large bridges (reduced structures for veneering with ceramics)
ZIRKONZAHN SRL
ZRAB5501
In Commercial Distribution

  • D800ZRAB5501 ()


  • Dental bridge, ceramic
No Description
Trilliant Surgical, LLC
300-60-002
In Commercial Distribution

  • 00812926025445 ()

  • 9 Hole VL Gridlock Fibula Plate


  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
No Description
Acuitive Technologies, Inc.
30-103-0933
In Commercial Distribution

  • 00810027270634 ()
30-103-0933

  • Tendon/ligament bone anchor, bioabsorbable
No Description
Acuitive Technologies, Inc.
30-103-0928
In Commercial Distribution

  • 00810027270627 ()
30-103-0928

  • Tendon/ligament bone anchor, bioabsorbable
No Description
Acuitive Technologies, Inc.
30-103-0923
In Commercial Distribution

  • 00810027270610 ()
30-103-0923

  • Tendon/ligament bone anchor, bioabsorbable
No Description
Laborie Medical Technologies Canada ULC
9021P5091
In Commercial Distribution

  • 20627825007102 ()
  • 10627825007105 ()
  • 30627825007109 ()


  • Urodynamic manometric catheter, non-electronic
No Description
MIPM Mammendorfer Institut für Physik und Medizin GmbH
Infant 9 - 15 cm
In Commercial Distribution

  • EMIP51000380 ()
5100038

  • Blood pressure cuff, reusable
No Description
HIOSSEN, INC.
TRYHYD09
In Commercial Distribution

  • 00810126041951 ()


  • Dental implant suprastructure, temporary, preformed, single-use
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