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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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HeliMEND and HeliMEND Advanced absorbable collagen membranes are made from purified bovine tendon. These collagen products provide wound stabilization and create space during guided tissue regeneration procedures where a longer absorption rate is desired. HeliMEND Advanced collagen membrane is absorbed within 18 weeks.
Integra Lifesciences Corporation
62207
In Commercial Distribution

  • 30381780038522 ()
  • 10381780038528 ()
  • M269622071 ()

  • 20mmx30mm
62207

  • Dental/maxillofacial soft-tissue biomatrix implant, animal-derived
HeliMEND and HeliMEND Advanced absorbable collagen membranes are made from purified bovine tendon. These collagen products provide wound stabilization and create space during guided tissue regeneration procedures where a longer absorption rate is desired. HeliMEND Advanced collagen membrane is absorbed within 18 weeks.
Integra Lifesciences Corporation
62206
In Commercial Distribution

  • 30381780038515 ()
  • 10381780038511 ()
  • M269622061 ()

  • 15mmx20mm
62206

  • Dental/maxillofacial soft-tissue biomatrix implant, animal-derived
HeliMEND and HeliMEND Advanced absorbable collagen membranes are made from purified bovine tendon. These collagen products provide wound stabilization and create space during guided tissue regeneration procedures where a longer absorption rate is desired. HeliMEND Advanced collagen membrane is absorbed within 18 weeks.
Integra Lifesciences Corporation
62205
In Commercial Distribution

  • 30381780038508 ()
  • 10381780038504 ()
  • M269622051 ()

  • 30 mm x 40 mm
62205

  • Dental/maxillofacial soft-tissue biomatrix implant, animal-derived
HeliMEND and HeliMEND Advanced absorbable collagen membranes are made from purified bovine tendon. These collagen products provide wound stabilization and create space during guided tissue regeneration procedures where a longer absorption rate is desired. HeliMEND Advanced collagen membrane is absorbed within 18 weeks.
Integra Lifesciences Corporation
62204
In Commercial Distribution

  • 30381780038492 ()
  • 10381780038498 ()
  • M269622041 ()

  • 20mmx30mm
62204

  • Dental/maxillofacial soft-tissue biomatrix implant, animal-derived
HeliMEND and HeliMEND Advanced absorbable collagen membranes are made from purified bovine tendon. These collagen products provide wound stabilization and create space during guided tissue regeneration procedures where a longer absorption rate is desired. HeliMEND Advanced collagen membrane is absorbed within 18 weeks.
Integra Lifesciences Corporation
62203
In Commercial Distribution

  • 30381780038485 ()
  • 10381780038481 ()
  • M269622031 ()

  • 15mmx20mm
62203

  • Dental/maxillofacial soft-tissue biomatrix implant, animal-derived
Convenience Kit consisting of - QCT Pro Asynchronous Calibration Module, CliniQCT - QCT Bone Mineral Density Analysis Software - CTXA Hip Bone Mineral Densitometer - CTXA Hip Extended Reference Database - Model 4 Calibration Phantom
MINDWAYS SOFTWARE, INC.
K894854K002113K030330K140342
In Commercial Distribution

  • B052QCTPROM4ASH0 ()
  • QCTPROM4ASHN0100 ()
  • QCTPROM4ASHN0075 ()
  • QCTPROM4ASHN0050 ()
  • QCTPROM4ASHN0025 ()
  • QCTPROM4ASHN0010 ()
  • QCTPROM4ASHN0005 ()
  • QCTPROM4ASHN0003 ()
  • QCTPROM4ASHN0002 ()
  • QCTPROM4ASHN0500 ()
  • QCTPROM4ASHN0200 ()
QCTPROM4ASH

  • CT system application software
Convenience Kit consisting of - QCT Bone Mineral Density Analysis Software - CTXA Hip Bone Mineral Densitometer - CTXA Hip Extended Reference Database - Model 3 QA & Calibration Phantom Set
MINDWAYS SOFTWARE, INC.
K894854K002113K030330
In Commercial Distribution

  • B052QCTPROM3SSH0 ()
QCTPROM3SSH

  • CT system application software
Convenience Kit consisting of - QCT Bone Mineral Density Analysis Software, - Model 3 QA & Calibration Phantom Set and - Accessories.
MINDWAYS SOFTWARE, INC.
K894854
In Commercial Distribution

  • B052QCTPROM3SS0 ()
QCTPROM3SS

  • CT system application software
Convenience Kit consisting of - QCT Pro Asynchronous Calibration Module, CliniQCT - QCT Bone Mineral Density Analysis Software - CTXA Hip Bone Mineral Densitometer - CTXA Hip Extended Reference Database - Model 3 QA & Calibration Phantom Set
MINDWAYS SOFTWARE, INC.
K894854K002113K030330K140342
In Commercial Distribution

  • B052QCTPROM3ASH0 ()
QCTPROM3ASH

  • CT system application software
Convenience Kit consisting of - QCT Bone Mineral Density Analysis Software - CTXA Hip Bone Mineral Densitometer - CTXA Hip Extended Reference Database
MINDWAYS SOFTWARE, INC.
K894854K002113K030330
In Commercial Distribution

  • B052QCTPROM0SSH0 ()
QCTPROM0SSH

  • CT system application software
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