ARIX Humerus System Bone Plate

GUDID 08800089424764

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 08800089424764
• NIH Device Record Key: 75491f80-f782-4140-8084-9a338e94c5ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARIX Humerus System Bone Plate
• Version Model Number: 35-PLHU-A01-R
• Company DUNS: 688811603
• Company Name: Jeil Medical Corporation
• Device Count: 1
• 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	08800089424764 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230938

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08800089424764]

Moist Heat or Steam Sterilization

[08800089424764]

Moist Heat or Steam Sterilization

[08800089424764]

Moist Heat or Steam Sterilization

[08800089424764]

Moist Heat or Steam Sterilization

[08800089424764]

Moist Heat or Steam Sterilization

[08800089424764]

Moist Heat or Steam Sterilization

[08800089424764]

Moist Heat or Steam Sterilization

[08800089424764]

Moist Heat or Steam Sterilization

[08800089424764]

Moist Heat or Steam Sterilization

[08800089424764]

Moist Heat or Steam Sterilization

[08800089424764]

Moist Heat or Steam Sterilization

[08800089424764]

Moist Heat or Steam Sterilization

[08800089424764]

Moist Heat or Steam Sterilization

[08800089424764]

Moist Heat or Steam Sterilization

[08800089424764]

Moist Heat or Steam Sterilization

[08800089424764]

Moist Heat or Steam Sterilization

[08800089424764]

Moist Heat or Steam Sterilization

[08800089424764]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-17
• Device Publish Date: 2023-05-09

On-Brand Devices [ARIX Humerus System Bone Plate]

• 08800089424788: 35-PLHU-S01-R
• 08800089424771: 35-PLHU-S01-L
• 08800089424764: 35-PLHU-A01-R
• 08800089424757: 35-PLHU-A01-L
• 08806390851534: 35-PLHU-005-R
• 08806390851527: 35-PLHU-004-R
• 08806390851510: 35-PLHU-003-R
• 08806390851503: 35-PLHU-005-L
• 08806390851497: 35-PLHU-004-L
• 08806390851480: 35-PLHU-003-L