Home GUDID 00681490843829 INFUSE® Bone Graft
Primary DI 00681490843829
Brand INFUSE® Bone Graft
Company MEDTRONIC SOFAMOR DANEK, INC.
Model 7510800
Device description BONE GRAFT KIT 7510800 INFUSE LARGE II
Published 2014-09-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name MPW Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction NEK FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION NPZ Bone grafting material, dental, with biologic component
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MPW Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction Unknown 3 NEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction Unknown 3 NPZ Bone Grafting Material, Dental, With Biologic Component Dental 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00681490843829 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00681490843829 00681490843829 681490843829 0681490843829
GMDN Terms# Term, Definition table Term Definition Spinal fusion graft kit A collection of sterile devices used to induce new spinal bone tissue that consists of a metallic spinal fusion cage, a recombinant human bone morphogenetic protein, and a carrier/scaffold for the protein and resulting bone growth. The bone morphogenetic protein is placed on the carrier/scaffold which is inserted into the spinal fusion cage. The spinal fusion cage is implanted into the spine and new bone tissue is induced at the site of implantation. The device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD). This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 830350380 Device count 1 Combination product true Lot or batch true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850001118002 GEM 21S® LYNCH BIOLOGICS, LLC NPZ 2018-10-18 EFRIUS99U000102 Symbios ™ Dentsply Implants Manufacturing GmbH NPZ 2014-12-02 ERFIUS930000104 Symbios ™ Dentsply Implants Manufacturing GmbH NPZ 2014-12-02 ERFIUS930000304 Symbios ™ Dentsply Implants Manufacturing GmbH NPZ 2014-12-02 ERFIUS970000104 Symbios ™ Dentsply Implants Manufacturing GmbH NPZ 2014-12-02 ERFIUS970000304 Symbios ™ Dentsply Implants Manufacturing GmbH NPZ 2014-12-02 ERFIUS99U00014 Symbios ™ Dentsply Implants Manufacturing GmbH NPZ 2014-12-02 ERFIUS99U000302 Symbios ™ Dentsply Implants Manufacturing GmbH NPZ 2014-12-02 ERFIUS99U100052 Symbios ™ Dentsply Implants Manufacturing GmbH NPZ 2014-12-02 ERFIUS99U100054 Symbios ™ Dentsply Implants Manufacturing GmbH NPZ 2014-12-02 ERFIUS99U100102 Symbios ™ Dentsply Implants Manufacturing GmbH NPZ 2014-12-02 ERFIUS99U100104 Symbios ™ Dentsply Implants Manufacturing GmbH NPZ 2014-12-02 00681490843782 INFUSE® Bone Graft MEDTRONIC SOFAMOR DANEK, INC. NEK 2014-09-23 00681490843782 INFUSE® Bone Graft MEDTRONIC SOFAMOR DANEK, INC. NPZ 2014-09-23 00681490843805 INFUSE® Bone Graft MEDTRONIC SOFAMOR DANEK, INC. NEK 2014-09-23 00681490843805 INFUSE® Bone Graft MEDTRONIC SOFAMOR DANEK, INC. NPZ 2014-09-23 00681490843812 INFUSE® Bone Graft MEDTRONIC SOFAMOR DANEK, INC. NEK 2014-09-23 00681490843812 INFUSE® Bone Graft MEDTRONIC SOFAMOR DANEK, INC. NPZ 2014-09-23 00613994239518 INFUSE® Bone Graft MEDTRONIC SOFAMOR DANEK, INC. NPZ 2014-09-23 00613994239518 INFUSE® Bone Graft MEDTRONIC SOFAMOR DANEK, INC. NEK 2014-09-23 00613994239525 INFUSE® Bone Graft MEDTRONIC SOFAMOR DANEK, INC. NPZ 2014-09-23 00613994239525 INFUSE® Bone Graft MEDTRONIC SOFAMOR DANEK, INC. NEK 2014-09-23
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