SpF XL IIb Implantable Spinal Fusion Stimulator 10-1335M

GUDID 00812301020089

Patient-worn bone growth electromagnetic stimulator

Primary Device ID	00812301020089
NIH Device Record Key	66b0493a-bb74-47fb-866e-0a8855ba558f
Commercial Distribution Status	In Commercial Distribution
Brand Name	SpF XL IIb Implantable Spinal Fusion Stimulator
Version Model Number	10-1335M
Catalog Number	10-1335M
Company DUNS	050410323
Company Name	EBI, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	true
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00812301020089 [Primary]

LOE	Stimulator, Invasive Bone Growth

Steralize Prior To Use	false
Device Is Sterile	true

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