ARIX Ankle System Bone Plate

GUDID 08806390874243

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Primary Device ID08806390874243
NIH Device Record Key99c5e0c8-9c2c-4bfb-a68a-37fb556312a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameARIX Ankle System Bone Plate
Version Model Number35V-DLF2-005-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
GS108806390874243 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806390874243]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-03
Device Publish Date2020-03-26

On-Brand Devices [ARIX Ankle System Bone Plate]

0880639087427435V-DLF2-008-L
0880639087426735V-DLF2-007-L
0880639087425035V-DLF2-006-L
0880639087424335V-DLF2-005-L
0880639087423635V-DLF2-004-L
0880639087422935V-DLF2-003-L
0880639087421235V-DLF2-008-R
0880639087420535V-DLF2-007-R
0880639087419935V-DLF2-006-R
0880639087418235V-DLF2-005-R
0880639087417535V-DLF2-004-R
0880639087416835V-DLF2-003-R
0880008943434335V-DLF3-008-R
0880008943433635V-DLF3-008-L
0880008943432935V-DLF3-007-R
0880008943431235V-DLF3-007-L
0880008943430535V-DLF3-006-R
0880008943429935V-DLF3-006-L
0880008943428235V-DLF3-005-R
0880008943427535V-DLF3-005-L
0880008943426835V-DLF3-004-R
0880008943425135V-DLF3-004-L
0880008943424435V-DLF3-003-R
0880008943423735V-DLF3-003-L
0880639080143035-DLST-009
0880639080020435-DLST-010
0880639080018135-DLST-008
0880639080017435-DLST-007
0880639080016735-DLST-006
0880639080015035-DLST-005
0880639080014335-DLST-004
0880639080013635-DLST-003
0880639080012935-DLFI-008-R
0880639080011235-DLFI-007-R
0880639080010535-DLFI-006-R
0880639080009935-DLFI-005-R
0880639080008235-DLFI-004-R
0880639080007535-DLFI-003-R
0880639080006835-DLFI-008-L
0880639080005135-DLFI-007-L
0880639080004435-DLFI-006-L
0880639080003735-DLFI-005-L
0880639080002035-DLFI-004-L
0880639080001335-DLFI-003-L

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