ARIX Elbow System Bone Plate

GUDID 08806390881432

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Primary Device ID08806390881432
NIH Device Record Key1538b0e3-99d6-490c-808c-991c0b215459
Commercial Distribution StatusIn Commercial Distribution
Brand NameARIX Elbow System Bone Plate
Version Model Number35-PLUL-007-R
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
GS108806390881432 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806390881432]

Moist Heat or Steam Sterilization


[08806390881432]

Moist Heat or Steam Sterilization


[08806390881432]

Moist Heat or Steam Sterilization


[08806390881432]

Moist Heat or Steam Sterilization


[08806390881432]

Moist Heat or Steam Sterilization


[08806390881432]

Moist Heat or Steam Sterilization


[08806390881432]

Moist Heat or Steam Sterilization


[08806390881432]

Moist Heat or Steam Sterilization


[08806390881432]

Moist Heat or Steam Sterilization


[08806390881432]

Moist Heat or Steam Sterilization


[08806390881432]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-27
Device Publish Date2020-10-19

On-Brand Devices [ARIX Elbow System Bone Plate]

0880639088448835-DMHU-206-L
0880639088447135-DMHU-204-R
0880639088446435-DMHU-204-L
0880639088445735-DMHU-202-R
0880639088444035-DMHU-202-L
0880639088443335-DMHU-201-R
0880639088442635-DMHU-201-L
0880639088149435-PLUL-105-R
0880639088148735-PLUL-105-L
0880639088147035-PLUL-104-R
0880639088146335-PLUL-104-L
0880639088145635-PLUL-008-R
0880639088144935-PLUL-008-L
0880639088143235-PLUL-007-R
0880639088142535-PLUL-007-L
0880639088141835-PLUL-005-R
0880639088140135-PLUL-005-L
0880639088139535-PLUL-004-R
0880639088138835-PLUL-004-L
0880639088137135-DPHU-108-R
0880639088136435-DPHU-108-L
0880639088135735-DPHU-106-R
0880639088134035-DPHU-106-L
0880639088133335-DPHU-104-R
0880639088132635-DPHU-104-L
0880639088131935-DPHU-103-R
0880639088130235-DPHU-103-L
0880639088129635-DMHU-106-R
0880639088128935-DMHU-106-L
0880639088127235-DMHU-104-R
0880639088126535-DMHU-104-L
0880639088125835-DMHU-102-R
0880639088124135-DMHU-102-L
0880639088123435-DMHU-101-R
0880639088122735-DMHU-101-L
0880639088121035-DLHU-107-R
0880639088120335-DLHU-107-L
0880639088119735-DLHU-105-R
0880639088118035-DLHU-105-L
0880639088117335-DLHU-103-R
0880639088116635-DLHU-103-L
0880639088115935-DLHU-102-R
0880639088114235-DLHU-102-L
0880639088106725-PLUL-109
0880639088105025-PLUL-107
0880639088104325-PLUL-106
0880639088103625-PLUL-105
0880639088102925-PLUL-009
0880639088101225-PLUL-007
0880639088100525-PLUL-006

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