Octane Straight

GUDID 00840996155748

OCTANE,RASP STRAIGHT

Choice Spine, LP

Polymeric spinal interbody fusion cage

Primary Device ID	00840996155748
NIH Device Record Key	fd4cca18-490e-40a6-8cc3-df75a2234b58
Commercial Distribution Status	In Commercial Distribution
Brand Name	Octane Straight
Version Model Number	05-049-16-0000
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	00840996155748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K130434

FDA Product Code

LXH	Orthopedic manual surgical instrument

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

[00840996155748]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-03-04
Device Publish Date	2024-02-24

On-Brand Devices [Octane Straight]

00840996177375	Octane Straight Trail 24mmX10mmX15mm
00840996177368	Octane Straight Trail 24mmX10mmX14mm
00840996177351	Octane Straight Trail 24mmX10mmX13mm
00840996177344	Octane Straight Trail 24mmX10mmX12mm
00840996177337	Octane Straight Trail 24mmX10mmX11mm
00840996177320	Octane Straight Trail 24mmX10mmX10mm
00840996177313	Octane Straight Trail 24mmX10mmX9mm
00840996177306	Octane Straight Trail 24mmX10mmX8mm
00840996177290	Octane Straight Trail 24mmX10mmX7mm
00840996177283	Octane Straight Trail 24mmX10mmX6mm
00840996153669	OCTANE STR,NON THREAD OFF INSERTER
00840996150309	OCTANE STR,THREADED INSERTER BODY OFFSET
00840996155762	OCTANE M,RAIL REMOVAL TOOL
00840996155755	OCTANE,RASP ANGLED
00840996155748	OCTANE,RASP STRAIGHT
00840996155731	OCTANE,GRAFT TAMP
00840996155724	OCTANE,BOX CHISEL
00840996155717	OCTANE,SOLID IMPLANT INSERTER
00840996153652	OCTANE STR,THREADED INSERTER BODY OFFSE
00840996153645	OCTANE STR,NON THREAD INSERTER
00840996153638	OCTANE STR,SLAP HAMMER
00840996153621	OCTANE STRAIGHT,IMPLANT PUSHER,ANGLED
00840996153614	OCTANE STRAIGHT,IMPLANT PUSHER

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