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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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BELLAFILL - 00350224000028

Bellafill 0.8ml on 1.0cc syringe
SUNEVA MEDICAL, INC.
1.0 cc
In Commercial Distribution

  • 00350224000028 ()
  • 10350224000025 ()
  • 20350224000022 ()
GBF0208, GBF0508

  • Dermal tissue reconstructive material, animal-derived

OSSIX™ Bone - 07290015477222

OSSIX™ BONE is a biodegradable, osteoconductive, and biocompatible bone grafting material intended for guided tissue and bone regeneration. The OSSIX™ BONE matrix is composed of 80% synthetic crystalline non-sintered hydroxylapatite and 20% collagen, which is derived from veterinary certified pigs and is purified and cross-linked.
DATUM DENTAL LTD
0.250 cc
In Commercial Distribution

  • 07290015477222 ()

  • Height: 5 Millimeter
  • Length: 10 Millimeter
  • Depth: 5 Millimeter
  • 0.250 cc
OXB0250

  • Dental bone matrix implant, synthetic

OSSIX™ Bone - 07290015477215

OSSIX™ BONE is a biodegradable, osteoconductive, and biocompatible bone grafting material intended for guided tissue and bone regeneration. The OSSIX™ BONE matrix is composed of 80% synthetic crystalline non-sintered hydroxylapatite and 20% collagen, which is derived from veterinary certified pigs and is purified and cross-linked.
DATUM DENTAL LTD
0.125 cc
In Commercial Distribution

  • 07290015477215 ()

  • 0.125 cc
  • Depth: 5 Millimeter
  • Length: 5 Millimeter
  • Height: 5 Millimeter
OXB0125

  • Dental bone matrix implant, synthetic

OssDsign Catalyst - 07350086550733

OssDsign Catalyst is an osteoconductive, resorbable, porous, 100% nanosynthetic calcium phosphate bone void filler. OssDsign Catalyst contains 5.8 wt% silicon-substituted calcium phosphate granules suspended in a resorbable polymer gel. The final, finished OssDsign Catalyst is 30 wt% granules and 70 wt% polymer gel. The high surface area porous granules have been designed to deliver consistent and rapid bone ingrowth, remodeling and cell-mediated resorption during the bone healing process. The aqueous polymer gel phase binds the highly porous granules into a moldable, pliable formulation which enables OssDsign Catalyst to be implanted directly from the packaging without any further gelation, mixing or graft setting time. OssDsign Catalyst is provided sterile to the end user in 2.5 cc, 5 cc and 10 cc sizes. (510(k) no. K193075)
Ossdsign AB
1 cc
In Commercial Distribution

  • 07350086550733 ()
104010

  • Bone matrix implant, synthetic, non-antimicrobial

Corplex P - 00860471002572

Corplex P is derived from human umbilical cord extracellular matrix (ECM) and is indicated for the management of a range of acute and chronic wounds. As a resorbable particulate device, Corplex P/Theracor P/Allacor P is lyophilized and packaged in a sterile vial, allowing the device to be rehydrated and applied directly to the wound.
Stimlabs LLC
4 cc
In Commercial Distribution

  • 00860471002572 ()
CP-0040

  • Animal-derived wound matrix dressing

Corplex P - 00860471002565

Corplex P is derived from human umbilical cord extracellular matrix (ECM) and is indicated for the management of a range of acute and chronic wounds. As a resorbable particulate device, Corplex P/Theracor P/Allacor P is lyophilized and packaged in a sterile vial, allowing the device to be rehydrated and applied directly to the wound.
Stimlabs LLC
2 cc
In Commercial Distribution

  • 00860471002565 ()
CP0020

  • Animal-derived wound matrix dressing

Corplex P - 00860471002558

Corplex P is derived from human umbilical cord extracellular matrix (ECM) and is indicated for the management of a range of acute and chronic wounds. As a resorbable particulate device, Corplex P is lyophilized and packaged in a sterile vial, allowing the device to be rehydrated and applied directly to the wound.
Stimlabs LLC
1 cc
In Commercial Distribution

  • 00860471002558 ()
CP-0010

  • Animal-derived wound matrix dressing

Allacor P - 00850039927362

Allacor P is derived from human umbilical cord extracellular matrix (ECM) and is indicated for the management of a range of acute and chronic wounds. As a resorbable particulate device, Allacor P is lyophilized and packaged in a sterile vial, allowing the device to be rehydrated and applied directly to the wound.
Stimlabs LLC
4 cc
In Commercial Distribution

  • 00850039927362 ()
AP-0040

  • Animal-derived wound matrix dressing

Allacor P - 00850039927355

Allacor P is derived from human umbilical cord extracellular matrix (ECM) and is indicated for the management of a range of acute and chronic wounds. As a resorbable particulate device, Allacor P is lyophilized and packaged in a sterile vial, allowing the device to be rehydrated and applied directly to the wound.
Stimlabs LLC
2 cc
In Commercial Distribution

  • 00850039927355 ()
AP-0020

  • Animal-derived wound matrix dressing

Allacor P - 00850039927348

Allacor P is derived from human umbilical cord extracellular matrix (ECM) and is indicated for the management of a range of acute and chronic wounds. As a resorbable particulate device, Allacor P is lyophilized and packaged in a sterile vial, allowing the device to be rehydrated and applied directly to the wound.
Stimlabs LLC
1 cc
In Commercial Distribution

  • 00850039927348 ()
AP-0010

  • Animal-derived wound matrix dressing
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