ARIX Rib System Bone Plate

GUDID 08806390880411

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 08806390880411
• NIH Device Record Key: a45f312a-8d23-49d4-a26a-e648161d5aba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARIX Rib System Bone Plate
• Version Model Number: 24-STRB-010
• 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	08806390880411 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221412

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08806390880411]

Moist Heat or Steam Sterilization

[08806390880411]

Moist Heat or Steam Sterilization

[08806390880411]

Moist Heat or Steam Sterilization

[08806390880411]

Moist Heat or Steam Sterilization

[08806390880411]

Moist Heat or Steam Sterilization

[08806390880411]

Moist Heat or Steam Sterilization

[08806390880411]

Moist Heat or Steam Sterilization

[08806390880411]

Moist Heat or Steam Sterilization

[08806390880411]

Moist Heat or Steam Sterilization

[08806390880411]

Moist Heat or Steam Sterilization

[08806390880411]

Moist Heat or Steam Sterilization

[08806390880411]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-14
• Device Publish Date: 2022-12-06

On-Brand Devices [ARIX Rib System Bone Plate]

• 08806390880541: S24-STRB-010
• 08806390880534: S24-STRB-008
• 08806390880527: S24-STRB-006
• 08806390880510: S24-STRB-004
• 08806390880503: S24-CVRB-008
• 08806390880497: S24-CVRB-006
• 08806390880480: S24-CVRB-004
• 08806390880381: 24-STRB-004
• 08806390880411: 24-STRB-010
• 08806390880404: 24-STRB-008
• 08806390880398: 24-STRB-006
• 08806390880374: 24-CVRB-008
• 08806390880367: 24-CVRB-006
• 08806390880350: 24-CVRB-004