HARRIER-SA

GUDID 00840996186285

HARRIER-SA,INSERTER,OLIF

Choice Spine, LP

Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system
Primary Device ID00840996186285
NIH Device Record Keybdd0e916-a57d-42dc-82be-6ab4d7d033d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameHARRIER-SA
Version Model NumberY070-0058
Company DUNS078293017
Company NameChoice Spine, LP
Device Count1
DM Exempttrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996186285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996186285]

Moist Heat or Steam Sterilization


[00840996186285]

Moist Heat or Steam Sterilization


[00840996186285]

Moist Heat or Steam Sterilization


[00840996186285]

Moist Heat or Steam Sterilization


[00840996186285]

Moist Heat or Steam Sterilization


[00840996186285]

Moist Heat or Steam Sterilization


[00840996186285]

Moist Heat or Steam Sterilization


[00840996186285]

Moist Heat or Steam Sterilization


[00840996186285]

Moist Heat or Steam Sterilization


[00840996186285]

Moist Heat or Steam Sterilization


[00840996186285]

Moist Heat or Steam Sterilization


[00840996186285]

Moist Heat or Steam Sterilization


[00840996186285]

Moist Heat or Steam Sterilization


[00840996186285]

Moist Heat or Steam Sterilization


[00840996186285]

Moist Heat or Steam Sterilization


[00840996186285]

Moist Heat or Steam Sterilization


[00840996186285]

Moist Heat or Steam Sterilization


[00840996186285]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-14
Device Publish Date2023-07-06

On-Brand Devices [HARRIER-SA]

00840996187299HARRIER-SA,INSERTER,TRIAL,OFF ANGLE
00840996186285HARRIER-SA,INSERTER,OLIF
00840996186230HARRIER-SA,TRIAL,INSERTER,FIXED

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