ARIX

GUDID 08806390810739

Jeil Medical Corporation

Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding)

• Primary Device ID: 08806390810739
• NIH Device Record Key: 9add7c86-00ed-42a1-a18c-a416cf234b3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARIX
• Version Model Number: T141.011212
• Company DUNS: 688811603
• Company Name: Jeil Medical Corporation
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806390810739 [Primary]
GS1	08806390811965 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131566

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08806390810739]

Moist Heat or Steam Sterilization

[08806390810739]

Moist Heat or Steam Sterilization

[08806390810739]

Moist Heat or Steam Sterilization

[08806390810739]

Moist Heat or Steam Sterilization

[08806390810739]

Moist Heat or Steam Sterilization

[08806390810739]

Moist Heat or Steam Sterilization

[08806390810739]

Moist Heat or Steam Sterilization

[08806390810739]

Moist Heat or Steam Sterilization

[08806390810739]

Moist Heat or Steam Sterilization

[08806390810739]

Moist Heat or Steam Sterilization

[08806390810739]

Moist Heat or Steam Sterilization

[08806390810739]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2024-06-05
• Device Publish Date: 2016-03-15

On-Brand Devices [ARIX]

• 08806390819954: T141.012022.H
• 08806390819947: T141.012021.H
• 08806390819930: T141.012020.H
• 08806390819923: T141.012019.H
• 08806390819916: T141.012018.H
• 08806390819909: T141.012016.H
• 08806390819893: T141.012015.H
• 08806390819886: T141.012014.H
• 08806390819879: T141.012013.H
• 08806390819862: T141.012012.H
• 08806390819855: T141.012011.H
• 08806390819848: T141.012010.H
• 08806390819831: T141.012009.H
• 08806390819824: T141.012008.H
• 08806390819817: T141.012007.H
• 08806390819800: T141.012006.H
• 08806390819794: T141.012510
• 08806390819787: T141.012506
• 08806390819770: T141.012334
• 08806390819763: T141.012332
• 08806390819756: T141.012330
• 08806390819749: T141.012328
• 08806390819732: T141.012326
• 08806390819725: T141.012324
• 08806390819718: T141.012323
• 08806390819701: T141.012322
• 08806390819695: T141.012321
• 08806390819688: T141.012320
• 08806390819671: T141.012319
• 08806390819664: T141.012318
• 08806390819657: T141.012317
• 08806390819640: T141.012316
• 08806390819633: T141.012315
• 08806390816663: T141.012310
• 08806390816656: T141.012309
• 08806390816649: T141.012308
• 08806390816632: T141.012307
• 08806390816625: T141.012306
• 08806390816618: T141.012305
• 08806390816601: T141.012024
• 08806390816595: T141.012023
• 08806390816588: T141.012022
• 08806390816571: T141.012021
• 08806390816564: T141.012020
• 08806390816557: T141.012019
• 08806390816540: T141.012018
• 08806390816533: T141.012017
• 08806390816526: T141.012016
• 08806390816519: T141.012015
• 08806390807777: T141.011514