ARIX Small Fragment System

GUDID 08800089404148

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Primary Device ID08800089404148
NIH Device Record Key5db167ba-5be8-4c2b-854c-c2e9c97153a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameARIX Small Fragment System
Version Model Number25-SFTR-014
Company DUNS688811603
Company NameJeil Medical Corporation
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 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
GS108800089404148 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


[08800089404148]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-06
Device Publish Date2022-08-29

On-Brand Devices [ARIX Small Fragment System]

0880008940418625-SFTS-112
0880008940417925-SFTS-108
0880008940416225-SFTS-010
0880008940415525-SFTS-008
0880008940414825-SFTR-014
0880008940413125-SFTR-012
0880008940412425-SFST-020
0880008940411725-SFST-010
0880008940410025-SFST-008
0880008940409425-SFST-006
0880008940408725-SFST-004

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