Home GUDID 00812301020096 SpF®-XL IIb Implantable Spinal Fusion Stimulator
Primary DI 00812301020096
Brand SpF®-XL IIb Implantable Spinal Fusion Stimulator
Company EBI, LLC
Model 10-1335W
Catalog number 10-1335W
Device description SPF-XL IIB 2/DW
Published 2014-09-19
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name LOE Stimulator, Invasive Bone Growth
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LOE Stimulator, Invasive Bone Growth Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00812301020096 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 00812301020096 00812301020096 812301020096 0812301020096
GMDN Terms# Term, Definition table Term Definition Patient-worn bone growth electromagnetic stimulator A battery-powered, body-worn device designed to apply an electrical stimulus directly to bone to promote bone formation (i.e., osteogenesis). It is intended to generate an electromagnetic (EM) field (and its associated induced voltage effects) around a fracture or fusion site; it is not intended to apply an electric current directly to the body. The device is used as an alternative to bone grafting for non-union fractures (a condition in which the ends of a fractured bone fail to unite), and as a spinal fusion adjunct in treating degenerative vertebral diseases. It is also known as an osteogenesis stimulator.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 41 Degrees Fahrenheit 77 Degrees Fahrenheit
Regulatory Flags# DUNS number 050410323 Device count 1 Lot or batch true Serial number true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00880304820852 Biomet SpinalPak / OrthoPak 106130-22 106130-22 2016-06-07 00812301020188 Biomet SpinalPak / OrthoPak 106130-12 106130-12 2014-09-19 00812301020201 Biomet SpinalPak / OrthoPak 106130-20 106130-20 2014-09-19 00812301020515 Biomet EBI Bone Healing System 1068226 1068226 2014-09-19 00888480588528 Reficio DBM Paste 20700221 2015-10-19 00888480588535 Reficio DBM Paste 20700321 2015-10-19 00888480588542 Reficio DBM Paste 20700421 2015-10-19 00888480588559 Reficio DBM Plus 20800521 2015-10-19 00888480588566 Reficio DBM Plus 20900321 2015-10-19 00888480588573 Reficio DBM Plus 20900421 2015-10-19 00888480588580 Reficio DBM Plus 20900521 2015-10-19 00887868269264 Biomet SpinalPak Non-invasive Spine Fusion Stimulator System 1067716-45 1067716-45 2019-02-28 00887868269271 Biomet SpinalPak Non-invasive Spine Fusion Stimulator System 1067716-63 1067716-63 2019-02-28 00887868269288 Biomet SpinalPak Non-invasive Spine Fusion Stimulator System 1067716-72 1067716-72 2019-02-28 00887868269295 Biomet OrthoPak Non-invasive Bone Growth Stimulator System 1067718-45 1067718-45 2019-02-28 00887868269301 Biomet OrthoPak Non-invasive Bone Growth Stimulator System 1067718-63 1067718-63 2019-02-28 00887868269318 Biomet OrthoPak Non-invasive Bone Growth Stimulator System 1067718-72 1067718-72 2019-02-28 00880304820845 Biomet SpinalPak / OrthoPak 106130-14 106130-14 2016-06-07 00812301020010 EBI OsteoGen Implantable Bone Growth Stimulator 10-1318 10-1318 2014-09-19 00812301020027 EBI OsteoGen™ Implantable Bone Growth Stimulator 10-1320 10-1320 2014-09-19
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00812301020010 EBI OsteoGen Implantable Bone Growth Stimulator EBI, LLC LOE 2014-09-19 00812301020027 EBI OsteoGen™ Implantable Bone Growth Stimulator EBI, LLC LOE 2014-09-19 00812301020034 EBI OsteoGen™ Implantable Bone Growth Stimulator EBI, LLC LOE 2014-09-19 00812301020041 EBI OsteoGen™ Implantable Bone Growth Stimulator EBI, LLC LOE 2014-09-19 00812301020058 EBI OsteoGen™ Implantable Bone Growth Stimulator EBI, LLC LOE 2014-09-19 00812301020065 EBI OsteoGen™ Implantable Bone Growth Stimulator EBI, LLC LOE 2014-09-19 00812301020072 EBI OsteoGen™ Implantable Bone Growth Stimulator EBI, LLC LOE 2014-09-19 00812301020089 SpF XL IIb Implantable Spinal Fusion Stimulator EBI, LLC LOE 2014-09-19 00812301020102 EBI OsteoGen™ Implantable Bone Growth Stimulator EBI, LLC LOE 2014-09-19 00812301020119 EBI OsteoGen™ Implantable Bone Growth Stimulator EBI, LLC LOE 2014-09-19 00812301020126 SpF®-PLUS-Mini (60 uA/M) EBI, LLC LOE 2014-09-19 00812301020133 SpF®-PLUS-Mini (60 uA/W) EBI, LLC LOE 2014-09-19
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