HARRIER-SA Lumber Interbody System

GUDID 00840996171007

HARRIER-SA,STERILE,COVERPLATE,ZERO,12

Choice Spine, LP

Intervertebral-body internal spinal fixation system
Primary Device ID00840996171007
NIH Device Record Key3fb67efa-931d-418a-84e9-94d540f48fc4
Commercial Distribution StatusIn Commercial Distribution
Brand NameHARRIER-SA Lumber Interbody System
Version Model NumberS-YT40-Z012
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 Datetrue
Expiration Datetrue
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
GS100840996171007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-20
Device Publish Date2018-08-20

On-Brand Devices [HARRIER-SA Lumber Interbody System]

00840996171038HARRIER-SA,STERILE,COVERPLATE,ZERO,17
00840996171007HARRIER-SA,STERILE,COVERPLATE,ZERO,12

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