Gibralt Spine System

GUDID 00840996160674

Bone-screw internal spinal fixation system, non-sterile

Primary Device ID	00840996160674
NIH Device Record Key	b85c35ae-c94f-4900-8afd-6e23085f62b0
Commercial Distribution Status	In Commercial Distribution
Brand Name	Gibralt Spine System
Version Model Number	05-004-00-0000
Company DUNS	078293017
Company Name	Choice Spine, LP
Device Count	1
DM Exempt	false
Pre-market Exempt	true
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 Issuing Agency	Device ID
GS1	00840996160674 [Primary]

LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Steralize Prior To Use	true
Device Is Sterile	false

[00840996160674]

Moist Heat or Steam Sterilization

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