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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 bioBLOCK Subtalar Implant consists of a soft-threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint, trial implant and the corresponding instrumentation to facilitate insertion. The implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement. The implant is indicated as an internal support in the treatment of flat foot, providing structural support.
Ascension Orthopedics, Inc.
040010
In Commercial Distribution

  • M2480400100 ()
  • 10381780066576 ()

  • 10 mm dia x 15 mm L
040010

  • Subtalar implant, non-bioabsorbable
The bioBLOCK Subtalar Implant consists of a soft-threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint, trial implant and the corresponding instrumentation to facilitate insertion. The implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement. The implant is indicated as an internal support in the treatment of flat foot, providing structural support.
Ascension Orthopedics, Inc.
040009
In Commercial Distribution

  • M2480400090 ()
  • 10381780066569 ()

  • 9 mm dia x 15 mm L
040009

  • Subtalar implant, non-bioabsorbable
The bioBLOCK Subtalar Implant consists of a soft-threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint, trial implant and the corresponding instrumentation to facilitate insertion. The implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement. The implant is indicated as an internal support in the treatment of flat foot, providing structural support.
Ascension Orthopedics, Inc.
040008
In Commercial Distribution

  • M2480400080 ()
  • 10381780066552 ()

  • 8 mm dia x 15 mm L
040008

  • Subtalar implant, non-bioabsorbable
Radiesse Injectable Implant is a volumizing filler indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Radiesse Volumizing Filler Kit contains (1) injectable implant and (2) 27 gauge thin walled x 0.75 inch needles.
MERZ NORTH AMERICA, INC.
8071M0K1
In Commercial Distribution

  • M2138071M0K15 ()

  • Total Volume: 1.5 Milliliter


  • Dermal tissue reconstructive material, synthetic mineral
Radiesse Injectable Implant is a volumizing filler indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Radiesse Volumizing Filler Kit contains (1) injectable implant and (2) 27 gauge thin walled x 0.75 inch needles.
MERZ NORTH AMERICA, INC.
8069M0K1
In Commercial Distribution

  • M2138069M0K15 ()

  • Total Volume: 0.8 Milliliter


  • Dermal tissue reconstructive material, synthetic mineral
Radiesse Injectable Implant is a volumizing filler indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Radiesse Volumizing Filler Kit contains (2) injectable implants and (4) 27 gauge thin walled x 0.75 inch needles.
MERZ NORTH AMERICA, INC.
8071M0K2
In Commercial Distribution

  • M2138071M0K25 ()
  • M2138071M0K22 ()

  • Total Volume: 3.0 Milliliter


  • Dermal tissue reconstructive material, synthetic mineral
The CustomFlex Artificial Iris is a prosthetic iris (the colored part of the eye around the pupil) made of thin, foldable medical-grade silicone. This device is custom-made and can be sized and colored for each individual patient. This with Fiber model has a polyester meshwork layer embedded in it to provide adequate tear strength to withstand suturing. The CustomFlex Artificial Iris can be used to treat congenital (genetic disorder in which the iris is completely or partially absent) and traumatic aniridia.It can also be used to treat iris defects due to other reasons or conditions, such as albinism, or surgical removal due to melanoma.
HumanOptics AG
95001
In Commercial Distribution

  • 04049154000012 ()

  • Outer Diameter: 12.8 Millimeter
00095001

  • Implantable iris prosthesis
The Occlutech Pistol Pusher is a medical device compatible with the Occlutech Atrial Septal Defect Occluder (Occlutech ASD Occluder) and applications with special cardiac catheters in the human heart.The Occlutech Pistol Pusher is composed of proximal body and distal parts. The distal part consists of titanium alloy jaws and a stainless-steel container while the body part is polymer laminated stainless steel coil. The proximal parts of the Occlutech Pistol Pusher largely contains plastic components. The jaws and container mechanism grab and secure the ball connector of the compatible Occlutech ASD Occluder and allow retraction of the Occlutech ASD Occluder into the ODS III and advancement to the implant area. The proximal part has a trigger for releasing the compatible Occlutech ASD Occluder and a locking mechanism for locking the system to prevent unintentional release. The Occlutech Pistol Pusher is available in different sizes for compatibility with the Occlutech ASD Occluders.
OCCLUTECH TIBBI URUNLER SANAYI VE TICARET LIMITED SIRKETI
38PP210
In Commercial Distribution

  • 08683463400222 ()

  • Outer Diameter: 3.23 Millimeter
  • Length: 120 Centimeter
38PP210

  • Cardiac defect occluder
The Occlutech Pistol Pusher is a medical device compatible with the Occlutech Atrial Septal Defect Occluder (Occlutech ASD Occluder) and applications with special cardiac catheters in the human heart.The Occlutech Pistol Pusher is composed of proximal body and distal parts. The distal part consists of titanium alloy jaws and a stainless-steel container while the body part is polymer laminated stainless steel coil. The proximal parts of the Occlutech Pistol Pusher largely contains plastic components. The jaws and container mechanism grab and secure the ball connector of the compatible Occlutech ASD Occluder and allow retraction of the Occlutech ASD Occluder into the ODS III and advancement to the implant area. The proximal part has a trigger for releasing the compatible Occlutech ASD Occluder and a locking mechanism for locking the system to prevent unintentional release. The Occlutech Pistol Pusher is available in different sizes for compatibility with the Occlutech ASD Occluders.
OCCLUTECH TIBBI URUNLER SANAYI VE TICARET LIMITED SIRKETI
38PP185
In Commercial Distribution

  • 08683463400208 ()

  • Outer Diameter: 2.93 Millimeter
  • Length: 120 Centimeter
38PP185

  • Cardiac defect occluder
The Occlutech Pistol Pusher is a medical device compatible with the Occlutech Atrial Septal Defect Occluder (Occlutech ASD Occluder) and applications with special cardiac catheters in the human heart.The Occlutech Pistol Pusher is composed of proximal body and distal parts. The distal part consists of titanium alloy jaws and a stainless-steel container while the body part is polymer laminated stainless steel coil. The proximal parts of the Occlutech Pistol Pusher largely contains plastic components. The jaws and container mechanism grab and secure the ball connector of the compatible Occlutech ASD Occluder and allow retraction of the Occlutech ASD Occluder into the ODS III and advancement to the implant area. The proximal part has a trigger for releasing the compatible Occlutech ASD Occluder and a locking mechanism for locking the system to prevent unintentional release. The Occlutech Pistol Pusher is available in different sizes for compatibility with the Occlutech ASD Occluders.
OCCLUTECH TIBBI URUNLER SANAYI VE TICARET LIMITED SIRKETI
38PP165
In Commercial Distribution

  • 08683463400185 ()

  • Outer Diameter: 2.73 Millimeter
  • Length: 120 Centimeter
38PP165

  • Cardiac defect occluder
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