ARIX Foot System Bone Plate

GUDID 08806390849135

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable
Primary Device ID08806390849135
NIH Device Record Key3fcb80c0-faf0-4621-a4dd-cba2d8828f24
Commercial Distribution StatusIn Commercial Distribution
Brand NameARIX Foot System Bone Plate
Version Model Number35D-CLCC-004-L
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
GS108806390849135 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806390849135]

Moist Heat or Steam Sterilization


[08806390849135]

Moist Heat or Steam Sterilization


[08806390849135]

Moist Heat or Steam Sterilization


[08806390849135]

Moist Heat or Steam Sterilization


[08806390849135]

Moist Heat or Steam Sterilization


[08806390849135]

Moist Heat or Steam Sterilization


[08806390849135]

Moist Heat or Steam Sterilization


[08806390849135]

Moist Heat or Steam Sterilization


[08806390849135]

Moist Heat or Steam Sterilization


[08806390849135]

Moist Heat or Steam Sterilization


[08806390849135]

Moist Heat or Steam Sterilization


[08806390849135]

Moist Heat or Steam Sterilization


[08806390849135]

Moist Heat or Steam Sterilization


[08806390849135]

Moist Heat or Steam Sterilization


[08806390849135]

Moist Heat or Steam Sterilization


[08806390849135]

Moist Heat or Steam Sterilization


[08806390849135]

Moist Heat or Steam Sterilization


[08806390849135]

Moist Heat or Steam Sterilization


[08806390849135]

Moist Heat or Steam Sterilization


[08806390849135]

Moist Heat or Steam Sterilization


[08806390849135]

Moist Heat or Steam Sterilization


[08806390849135]

Moist Heat or Steam Sterilization


[08806390849135]

Moist Heat or Steam Sterilization


[08806390849135]

Moist Heat or Steam Sterilization


[08806390849135]

Moist Heat or Steam Sterilization


[08806390849135]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2024-06-04
Device Publish Date2017-09-05

On-Brand Devices [ARIX Foot System Bone Plate]

0880639084920335D-CLCC-304-R
0880639084919735D-CLCC-204-R
0880639084918035D-CLCC-104-R
0880639084917335D-CLCC-004-R
0880639084916635D-CLCC-304-L
0880639084915935D-CLCC-204-L
0880639084914235D-CLCC-104-L
0880639084913535D-CLCC-004-L
0880639084912835M-CLCC-306-R
0880639084911135M-CLCC-206-R
0880639084910435M-CLCC-106-R
0880639084909835M-CLCC-005-R
0880639084908135M-CLCC-306-L
0880639084907435M-CLCC-206-L
0880639084906735M-CLCC-106-L
0880639084905035M-CLCC-005-L
0880639084904335L-CLCC-313-R
0880639084903635L-CLCC-213-R
0880639084902935L-CLCC-113-R
0880639084901235L-CLCC-012-R
0880639084900535L-CLCC-313-L
0880639084899235L-CLCC-213-L
0880639084898535L-CLCC-113-L
0880639084897835L-CLCC-012-L
08806390854146F23-QR-008-13
08806390854054F28-TR-005-16
08806390854047F28-TR-004-16
08806390854030F28-TL-005-16
08806390854023F28-TL-004-16
08806390854016F28-XR-204-16
08806390854009F28-XR-104-16
08806390853996F28-XR-004-16
08806390853989F28-XL-204-16
08806390853972F28-XL-104-16
08806390853965F28-XL-004-16
08806390853958F28-LR-305-16
08806390853941F28-LR-304-16
08806390853934F28-LR-205-16
08806390853927F28-LR-204-16
08806390853910F28-LR-105-16
08806390853903F28-LR-104-16
08806390853897F28-LR-005-16
08806390853880F28-LR-004-16
08806390853873F28-LL-305-16
08806390853866F28-LL-304-16
08806390853859F28-LL-205-16
08806390853842F28-LL-204-16
08806390853835F28-LL-105-16
08806390853828F28-LL-104-16
08806390853811F28-LL-005-16

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