Harrier SA

GUDID 00840996184038

HARRIER-SA,SCREW,5.5X30

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840996184038
NIH Device Record Key87faada0-d3a8-4bde-acd9-0fefd9eda9ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameHarrier SA
Version Model NumberYT35-5530
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
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996184038 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996184038]

Moist Heat or Steam Sterilization

[00840996184038]

Moist Heat or Steam Sterilization

[00840996184038]

Moist Heat or Steam Sterilization

[00840996184038]

Moist Heat or Steam Sterilization

[00840996184038]

Moist Heat or Steam Sterilization

[00840996184038]

Moist Heat or Steam Sterilization

[00840996184038]

Moist Heat or Steam Sterilization

[00840996184038]

Moist Heat or Steam Sterilization

[00840996184038]

Moist Heat or Steam Sterilization

[00840996184038]

Moist Heat or Steam Sterilization

[00840996184038]

Moist Heat or Steam Sterilization

[00840996184038]

Moist Heat or Steam Sterilization

[00840996184038]

Moist Heat or Steam Sterilization

[00840996184038]

Moist Heat or Steam Sterilization

[00840996184038]

Moist Heat or Steam Sterilization

[00840996184038]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-13
Device Publish Date2023-02-03

On-Brand Devices [Harrier SA]

00840996177245Harrier SA 26x32x8, 10 Deg
0084099617723828x36x10,10deg Trial
0084099617722128x36x8,10deg Trial
00840996184052HARRIER-SA,SCREW,5.5X40
00840996184045HARRIER-SA,SCREW,5.5X35
00840996184038HARRIER-SA,SCREW,5.5X30
00840996184021HARRIER-SA,SCREW,5.5X25
00840996184014HARRIER-SA,SCREW,5.5X20
00840996184007HARRIER-SA,SCREW,5.0x35
00840996183994HARRIER-SA,SCREW,5.0x40
00840996183987HARRIER-SA,SCREW,5.0x30
00840996183970HARRIER-SA,SCREW,5.0x25
00840996183963HARRIER-SA,SCREW,5.0x20
00840996192965HARRIER-SA,TRIAL,START WEDGE IMPACT 6H
00840996192958HARRIER-SA,TRIAL,START WEDGE IMPACT 8H
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.