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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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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 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.
8071M0H1
In Commercial Distribution

  • M2138071M0H15 ()

  • 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 (+) Lidocaine Injectable Implant is a volumizing filler with lidocaine indicated for subdermal implamantation for the correction of moderate to severe folds, such as nasolabial folds. Radiesse (+) Kit contains (1) 0.8cc Injectable Implant and (2) 27 gauge thin walled x 0.75" needles.
MERZ NORTH AMERICA, INC.
8067M0K1
In Commercial Distribution

  • M2138067M0K15 ()

  • Total Volume: 0.8 Milliliter


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
Radiesse (+) Lidocaine 1.5cc Injectable Implant is a volumizing filler with integral lidocaine indicated for subdermal implamantation for the correction of moderate to severe folds, such as nasolabial folds. Radiesse (+) Kit contains (1) 1.5cc Injectable Implant and (2) 27 gauge thin walled x 0.75" needles.
MERZ NORTH AMERICA, INC.
8063M0K1
In Commercial Distribution

  • M2138063M0K15 ()

  • Total Volume: 1.5 Milliliter


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
Belotero Balance is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. Belotero Balance kit contains (1) injectable implant and 2 needles - 30 Gauge x 1/2 inch, and 27 Gauge x 1/2 inch.
MERZ NORTH AMERICA, INC.
8700M0
Not in Commercial Distribution

  • M2138700M05 ()

  • Total Volume: 1 Milliliter


  • Dermal tissue reconstructive material, microbe-derived
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. RADIESSE injectable implant is also indicated for hand augmentation to correct volume loss in the dorsum of the hands.
MERZ NORTH AMERICA, INC.
8071C0K1
In Commercial Distribution

  • M2138071C0K15 ()

  • Total Volume: 1.5 Milliliter


  • Dermal tissue reconstructive material, synthetic mineral
Linear ST, 70cm 8 Contact Trial Lead Kit
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-2218-70E
In Commercial Distribution

  • M365SC221870E0 ()

  • 70 cm Length
SC-2218-70E

  • Analgesic spinal cord electrical stimulation system
Linear ST, 70cm 8 Contact Lead Kit
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-2218-70
In Commercial Distribution

  • M365SC2218700 ()

  • 70 cm Length
SC-2218-70

  • Analgesic spinal cord electrical stimulation system
Linear ST, 50cm 8 Contact Trial Lead Kit
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-2258-50E
In Commercial Distribution

  • M365SC221850E0 ()

  • 50 cm Length
SC-2258-50E

  • Analgesic spinal cord electrical stimulation system
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