Gibralt Spine System

GUDID 00840996169912

GIBRALT,TAP,4.5

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840996169912
NIH Device Record Key2b082528-0e45-4143-91b5-8f6623b79cb1
Commercial Distribution StatusIn Commercial Distribution
Brand NameGibralt Spine System
Version Model Number05-009-98-1045
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

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996169912 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996169912]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-02-17

On-Brand Devices [Gibralt Spine System]

00840996169912GIBRALT,TAP,4.5
00840996169905GIBRALT,TAP,4.0
00840996169899GIBRALT,TAP,3.5
00840996169882GIBRALT,TAP,NO SLEEVE,4.5
00840996169875GIBRALT,TAP,NO SLEEVE,4.0
00840996169868GIBRALT,TAP,NO SLEEVE,3.5
00840996169851GIBRALT,TAP,NO SLEEVE,3.0
00840996169844GIBRALT,DRILL,ADUSTABLE,2.4
00840996166119GIBRALT,DRILL,ADUSTABLE,2.0
00840996160674GIBRALT, CONNECTOR, CAP
00840996150323GIBRALT,SET SCREW,DRIVER,RETAINING SHAFT

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