ARIX Rib System Bone Plate

GUDID 08806390880350

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Primary Device ID08806390880350
NIH Device Record Key87988a90-7f6f-4386-8761-5b64c5843544
Commercial Distribution StatusIn Commercial Distribution
Brand NameARIX Rib System Bone Plate
Version Model Number24-CVRB-004
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
GS108806390880350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806390880350]

Moist Heat or Steam Sterilization


[08806390880350]

Moist Heat or Steam Sterilization


[08806390880350]

Moist Heat or Steam Sterilization


[08806390880350]

Moist Heat or Steam Sterilization


[08806390880350]

Moist Heat or Steam Sterilization


[08806390880350]

Moist Heat or Steam Sterilization


[08806390880350]

Moist Heat or Steam Sterilization


[08806390880350]

Moist Heat or Steam Sterilization


[08806390880350]

Moist Heat or Steam Sterilization


[08806390880350]

Moist Heat or Steam Sterilization


[08806390880350]

Moist Heat or Steam Sterilization


[08806390880350]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-14
Device Publish Date2022-12-06

On-Brand Devices [ARIX Rib System Bone Plate]

08806390880541S24-STRB-010
08806390880534S24-STRB-008
08806390880527S24-STRB-006
08806390880510S24-STRB-004
08806390880503S24-CVRB-008
08806390880497S24-CVRB-006
08806390880480S24-CVRB-004
0880639088038124-STRB-004
0880639088041124-STRB-010
0880639088040424-STRB-008
0880639088039824-STRB-006
0880639088037424-CVRB-008
0880639088036724-CVRB-006
0880639088035024-CVRB-004

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