Octane P

GUDID 00840996154437

OCTANE P,PADDLE DISTRACTOR,15

Choice Spine, LP

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Primary Device ID	00840996154437
NIH Device Record Key	ae38d017-3798-44b1-a768-6e1cf87aa405
Commercial Distribution Status	In Commercial Distribution
Brand Name	Octane P
Version Model Number	601-9115
Company DUNS	078293017
Company Name	Choice Spine, LP
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996154437 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K082270

FDA Product Code

LXH	Orthopedic manual surgical instrument