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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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No Description
OXFORD PERFORMANCE MATERIALS, INC.
PK627050
In Commercial Distribution

  • 00810188321749 ()


  • Custom-made cranial bone prosthesis
No Description
OXFORD PERFORMANCE MATERIALS, INC.
PK627033
In Commercial Distribution

  • 00810188321565 ()


  • Custom-made cranial bone prosthesis
No Description
OXFORD PERFORMANCE MATERIALS, INC.
PK627046
In Commercial Distribution

  • 00810188321688 ()


  • Custom-made cranial bone prosthesis
Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Regenomer® is manufactured in three types, Regenomer® Syringe (sheet shape in syringe and blister), Regenomer® Plug (bullet shape in blister), and Regenomer® Block (block shape in blister). Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
Nibec Co., Ltd.
RSP2-L
In Commercial Distribution

  • 08809186549455 ()

  • 12mm X 25mm


  • Dental bone matrix implant, animal-derived
Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Regenomer® is manufactured in three types, Regenomer® Syringe (sheet shape in syringe and blister), Regenomer® Plug (bullet shape in blister), and Regenomer® Block (block shape in blister). Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
Nibec Co., Ltd.
RSP1-S
In Commercial Distribution

  • 08809186549448 ()

  • 8mm X 18mm


  • Dental bone matrix implant, animal-derived
Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Regenomer® is manufactured in three types, Regenomer® Syringe (sheet shape in syringe and blister), Regenomer® Plug (bullet shape in blister), and Regenomer® Block (block shape in blister). Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
Nibec Co., Ltd.
RSB2-L
In Commercial Distribution

  • 08809186549431 ()

  • 8mm X 7mm X 9mm


  • Dental bone matrix implant, animal-derived
Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Regenomer® is manufactured in three types, Regenomer® Syringe (sheet shape in syringe and blister), Regenomer® Plug (bullet shape in blister), and Regenomer® Block (block shape in blister). Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
Nibec Co., Ltd.
RSB1-S
In Commercial Distribution

  • 08809186549424 ()

  • 6mm X 5mm X 7mm


  • Dental bone matrix implant, animal-derived
Ti-Mesh 6" X 6" Light 35g/m²
pfm medical titanium gmbh
6000312
In Commercial Distribution

  • 04042301097606 ()
  • 04042301097613 ()


  • Pelvic organ prolapse surgical mesh, composite-polymer
Vertessa Lite Y 26x5x4cm polypropylene mesh for sacrocolpopexy
Caldera Medical, Inc.
CAL-VLY2654
In Commercial Distribution

  • 00890594000773 ()
  • 00890594000797 ()
  • 00890594000780 ()

  • 26 x 5 x 4cm


  • Pelvic organ prolapse surgical mesh, composite-polymer
Vertessa Lite Y 26x4x3cm polypropylene mesh for sacrocolpopexy
Caldera Medical, Inc.
CAL-VLY2643
In Commercial Distribution

  • 00890594000483 ()
  • 00890594000469 ()
  • 00890594000476 ()

  • 26x4x3cm


  • Pelvic organ prolapse surgical mesh, composite-polymer
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