Octane P

GUDID 00840996154451

OCTANE P,TRIAL,7

Choice Spine, LP

Polymeric spinal interbody fusion cage
Primary Device ID00840996154451
NIH Device Record Key138d737d-3942-43fc-81d7-fe9f9f643dc0
Commercial Distribution StatusIn Commercial Distribution
Brand NameOctane P
Version Model Number601-9207
Company DUNS078293017
Company NameChoice Spine, LP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996154451 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


[00840996154451]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-04
Device Publish Date2024-02-24

On-Brand Devices [Octane P]

00840996154505OCTANE P,TRIAL,17
00840996154499OCTANE P,TRIAL,15
00840996154482OCTANE P,TRIAL,13
00840996154475OCTANE P,TRIAL,11
00840996154468OCTANE P,TRIAL,9
00840996154451OCTANE P,TRIAL,7
00840996154444OCTANE P,PADDLE DISTRACTOR,17
00840996154437OCTANE P,PADDLE DISTRACTOR,15
00840996154420OCTANE P,PADDLE DISTRACTOR,13
00840996154413OCTANE P,PADDLE DISTRACTOR,11
00840996154406OCTANE P,PADDLE DISTRACTOR,9
00840996154390OCTANE P,PADDLE DISTRACTOR,7
00840996154383OCTANE P,GRAFT BLOCK

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