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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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ACDF IMPLANT KIT - 14X12MM STRAIGHT
Pressio, Inc
PS-01-1412S
In Commercial Distribution

  • 00850039803048 ()


  • Memory-alloy orthopaedic fixation plate
ACDF IMPLANT KIT - 20X12MM ANGLED
Pressio, Inc
PS-01-2012A
In Commercial Distribution

  • 00850039803031 ()


  • Memory-alloy orthopaedic fixation plate
ACDF IMPLANT KIT - 18X12MM ANGLED
Pressio, Inc
PS-01-1812A
In Commercial Distribution

  • 00850039803024 ()


  • Memory-alloy orthopaedic fixation plate
ACDF IMPLANT KIT - 16X12MM ANGLED
Pressio, Inc
PS-01-1612A
In Commercial Distribution

  • 00850039803017 ()


  • Memory-alloy orthopaedic fixation plate
ACDF IMPLANT KIT - 14X12MM ANGLED
Pressio, Inc
PS-01-1412A
In Commercial Distribution

  • 00850039803000 ()


  • Memory-alloy orthopaedic fixation plate
Straumann® 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. Straumann® Regenomer® is manufactured in three types, Straumann® Regenomer® Syringe (sheet shape in syringe and blister), Straumann® Regenomer® Plug (bullet shape in blister), and Straumann® Regenomer® Block (block shape in blister). Straumann® Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
Nibec Co., Ltd.
RSB2-L
In Commercial Distribution

  • 08809186542067 ()

  • 8mm X 7mm X 9mm


  • Dental bone matrix implant, animal-derived
Straumann® 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. Straumann® Regenomer® is manufactured in three types,Straumann® Regenomer® Syringe (sheet shape in syringe and blister), Straumann® Regenomer® Plug (bullet shape in blister), and Straumann® Regenomer® Block (block shape in blister). Straumann® Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
Nibec Co., Ltd.
RSB1-S
In Commercial Distribution

  • 08809186542050 ()

  • 6mm X 5mm X 7mm


  • Dental bone matrix implant, animal-derived
Straumann® 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. Straumann® Regenomer® is manufactured in three types, Straumann® Regenomer® Syringe (sheet shape in syringe and blister), Straumann® Regenomer® Plug (bullet shape in blister), and Straumann® Regenomer® Block (block shape in blister). Straumann® Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
Nibec Co., Ltd.
RSP2-L
In Commercial Distribution

  • 08809186542043 ()

  • 12mm X 25mm


  • Dental bone matrix implant, animal-derived
Straumann® 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. Straumann® Regenomer® is manufactured in three types, Straumann® Regenomer® Syringe (sheet shape in syringe and blister), Straumann® Regenomer® Plug (bullet shape in blister), and Straumann® Regenomer® Block (block shape in blister). Straumann® Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
Nibec Co., Ltd.
RSP1-S
In Commercial Distribution

  • 08809186542036 ()

  • 8mm X 18mm


  • Dental bone matrix implant, animal-derived
Shoulder Innovations InSet Plus Glenoid Implant, Circular In Line Peg, 33mm x 10°, UHMWPE
Shoulder Innovations, Inc.
33 mm x 10°
In Commercial Distribution

  • B1132N2AI330100 ()
2N2AI33010

  • Shoulder glenoid fossa prosthesis, prefabricated
  • Total shoulder prosthesis
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