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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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Prestige Coil System - 00810068567342

The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral vasculature. It is designed for use with the Ultra Detachment Controller.
BALT USA LLC
PRES0204CXPPLT
In Commercial Distribution

  • 00810068567342 ()

  • PRESTIGE PLUS COMPLEX XTRA PACK 2mm x 4cm


  • Non-neurovascular embolization coil

Prestige Coil System - 00810068567335

The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral vasculature. It is designed for use with the Ultra Detachment Controller.
BALT USA LLC
PRES0158CXPPLT
In Commercial Distribution

  • 00810068567335 ()

  • PRESTIGE PLUS COMPLEX XTRA PACK 1.5mm x 8cm


  • Non-neurovascular embolization coil

Prestige Coil System - 00810068567328

The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral vasculature. It is designed for use with the Ultra Detachment Controller.
BALT USA LLC
PRES0156CXPPLT
In Commercial Distribution

  • 00810068567328 ()

  • PRESTIGE PLUS COMPLEX XTRA PACK 1.5mm x 6cm


  • Non-neurovascular embolization coil

Prestige Coil System - 00810068567311

The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral vasculature. It is designed for use with the Ultra Detachment Controller.
BALT USA LLC
PRES0153CXPPLT
In Commercial Distribution

  • 00810068567311 ()

  • PRESTIGE PLUS COMPLEX XTRA PACK 1.5mm x 3cm


  • Non-neurovascular embolization coil

Gel-One® Cross-linked Hyaluronate - 04987541300911

Gel-One is a cross-linked hyaluronate hydrogel that is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics (e.g., acetaminophen). Gel-One is physician-administered, and is injected directly into the cavity of the knee joint. It is delivered via a single-use, pre-filled disposable glass syringe containing 3 mL of Gel-One.
SEIKAGAKU CORPORATION
00-1111-001-00
In Commercial Distribution

  • 04987541300911 ()
00-1111-001-00

  • Synovial fluid supplementation medium

ST - 08809458319229

The Stella is intended to be surgically placed in the upper or lower jawbone to provide support for prosthetic devices, such as artificial teeth, restoring the patient's chewing capabilities. The Stella is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading. The Stella Abutment is intended to be connected to the dental implant to retain the overdenture or partial denture.
Shinhung MST Co., Ltd.
STCLSW
In Commercial Distribution

  • 08809458319229 ()


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

ST - 08809458319212

The Stella is intended to be surgically placed in the upper or lower jawbone to provide support for prosthetic devices, such as artificial teeth, restoring the patient's chewing capabilities. The Stella is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading. The Stella Abutment is intended to be connected to the dental implant to retain the overdenture or partial denture.
Shinhung MST Co., Ltd.
STCLSR
In Commercial Distribution

  • 08809458319212 ()


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

ST - 08809458318277

The Stella is intended to be surgically placed in the upper or lower jawbone to provide support for prosthetic devices, such as artificial teeth, restoring the patient's chewing capabilities. The Stella is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading. The Stella Abutment is intended to be connected to the dental implant to retain the overdenture or partial denture.
Shinhung MST Co., Ltd.
STMAW00
In Commercial Distribution

  • 08809458318277 ()


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

ST - 08809458318253

The Stella is intended to be surgically placed in the upper or lower jawbone to provide support for prosthetic devices, such as artificial teeth, restoring the patient's chewing capabilities. The Stella is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading. The Stella Abutment is intended to be connected to the dental implant to retain the overdenture or partial denture.
Shinhung MST Co., Ltd.
STMAR00
In Commercial Distribution

  • 08809458318253 ()


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

ST - 08809458315412

The Stella is intended to be surgically placed in the upper or lower jawbone to provide support for prosthetic devices, such as artificial teeth, restoring the patient's chewing capabilities. The Stella is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading. The Stella Abutment is intended to be connected to the dental implant to retain the overdenture or partial denture.
Shinhung MST Co., Ltd.
STSPAW70
In Commercial Distribution

  • 08809458315412 ()


  • Dental implant suprastructure, permanent, preformed
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