Octane Straight IR

GUDID 00840996163729

OCTANE STRAIGHT IR, Ti, 36X10X12, 6 DEG

Choice Spine, LP

Polymeric spinal interbody fusion cage
Primary Device ID00840996163729
NIH Device Record Key705b1159-e1c8-490e-b463-5e2d9c008313
Commercial Distribution StatusIn Commercial Distribution
Brand NameOctane Straight IR
Version Model NumberPT23-36126
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 Usetrue
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

Customer Support Contacts

Phone+1(865)246-3333
Emailinfo@choicespine.net

Device Dimensions

Length10 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996163729 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MPQCONTAINER, SPECIMEN, URINE, DRUGS OF ABUSE, OVER THE COUNTER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996163729]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2017-09-20

On-Brand Devices [Octane Straight IR]

00840996163804OCTANE STRAIGHT IR, Ti, 32X10X15, 6 DEG
00840996163798OCTANE STRAIGHT IR, Ti, 32X10X14, 6 DEG
00840996163781OCTANE STRAIGHT IR, Ti, 32X10X13, 6 DEG
00840996163774OCTANE STRAIGHT IR, Ti, 32X10X12, 6 DEG
00840996163767OCTANE STRAIGHT IR, Ti, 32X10X11, 6 DEG
00840996163750OCTANE STRAIGHT IR, Ti, 36X10X15, 6 DEG
00840996163743OCTANE STRAIGHT IR, Ti, 36X10X14, 6 DEG
00840996163736OCTANE STRAIGHT IR, Ti, 36X10X13, 6 DEG
00840996163729OCTANE STRAIGHT IR, Ti, 36X10X12, 6 DEG
00840996163712OCTANE STRAIGHT IR, Ti, 36X10X11, 6 DEG

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