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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 KGTI phalangeal component is fixed by means of a stem, which is inserted into the medullary canal of the phalanx. The implant is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.
Ascension Orthopedics, Inc.
012012
Not in Commercial Distribution

  • M2480120121 ()
  • 10381780065463 ()

  • .734 in dia x .662 in L; Size 1
012012

  • Partial metatarsophalangeal joint prosthesis
The KGTI phalangeal component is fixed by means of a stem, which is inserted into the medullary canal of the phalanx. The implant is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.
Ascension Orthopedics, Inc.
012010
Not in Commercial Distribution

  • M2480120101 ()
  • 10381780065456 ()

  • .672 in dia x .662 in L; Size 0
012010

  • Partial metatarsophalangeal joint prosthesis
HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 1.6x1.6 inches intended for the treatment of Wounds, Burns, and Ulcers. HELICOLL collagen sheet is free of contaminants and US Patented for further unique physiological modification. HELICOLL collagen is biodegradable and highly bioactive matrix for capillary growth and tissue regeneration.
ENCOLL CORP.
HC1.6x1.6
In Commercial Distribution

  • 00860000744485 ()
  • 10860000744482 ()
HC1.6x1.6

  • Collagen wound matrix dressing
HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 1.2x1.6 inches intended for the treatment of Wounds, Burns, and Ulcers. HELICOLL collagen sheet is free of contaminants and US Patented for further unique physiological modification. HELICOLL collagen is biodegradable and highly bioactive matrix for capillary growth and tissue regeneration.
ENCOLL CORP.
HC1.2x1.6
In Commercial Distribution

  • 00860000744478 ()
  • 10860000744475 ()
HC1.2x1.6

  • Collagen wound matrix dressing
HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 0.8x1.6 inches intended for the treatment of Wounds, Burns, and Ulcers. HELICOLL collagen sheet is free of contaminants and US Patented for further unique physiological modification. HELICOLL collagen is biodegradable and highly bioactive matrix for capillary growth and tissue regeneration.
ENCOLL CORP.
HC0.8x1.6
In Commercial Distribution

  • 00860000744461 ()
  • 10860000744468 ()
HC0.8x1.6

  • Collagen wound matrix dressing
HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 8x8 inches intended for the treatment of Wounds, Burns, and Ulcers. HELICOLL collagen sheet is free of contaminants and US Patented for further unique physiological modification. HELICOLL collagen is biodegradable and highly bioactive matrix for capillary growth and tissue regeneration.
ENCOLL CORP.
HC8x8
In Commercial Distribution

  • 00860000744430 ()
  • 10860000744437 ()
HC8x8

  • Collagen wound matrix dressing
HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 4x4 inches intended for the treatment of Wounds, Burns, and Ulcers. HELICOLL collagen sheet is free of contaminants and US Patented for further unique physiological modification. HELICOLL collagen is biodegradable and highly bioactive matrix for capillary growth and tissue regeneration.
ENCOLL CORP.
HC4x4
In Commercial Distribution

  • 00860000744423 ()
  • 10860000744420 ()
HC4x4

  • Collagen wound matrix dressing
HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 2x4 inches intended for the treatment of Wounds, Burns, and Ulcers. HELICOLL collagen sheet is free of contaminants and US Patented for further unique physiological modification. HELICOLL collagen is biodegradable and highly bioactive matrix for capillary growth and tissue regeneration.
ENCOLL CORP.
HC2x4
In Commercial Distribution

  • 00860000744416 ()
  • 10860000744413 ()
HC2x4

  • Collagen wound matrix dressing
HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 2x2 inches intended for the treatment of Wounds, Burns, and Ulcers. HELICOLL collagen sheet is free of contaminants and US Patented for further unique physiological modification. HELICOLL collagen is biodegradable and highly bioactive matrix for capillary growth and tissue regeneration.
ENCOLL CORP.
HC2x2
In Commercial Distribution

  • 00860000744409 ()
  • 10860000744406 ()
HC2x2

  • Collagen wound matrix dressing
Comfortear™ Punctum Plugs are packaged sterile and pre-loaded individually on the ergonomically designed Comfortear™ Insertion Tool in an impact-minimizing tray. Packaged two (2) individual sterile trays per box, the Comfortear™ individual sterile trays reduce the potential for unnecessary waste when only a single occulder is required. Pedi, 0.5mm.
MICROSPECIALITIES, INC.
24-2004
In Commercial Distribution

  • 30810003223587 ()
  • 10810003223583 ()

  • Outer Diameter: 0.5 Millimeter
24-2004

  • Lacrimal punctum plug
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