ARIX Sternal System Bone Plate

GUDID 08806390884037

Jeil Medical Corporation

Sternal fixation device

• Primary Device ID: 08806390884037
• NIH Device Record Key: c7ebd36b-0a36-4113-88b5-988273b04d5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARIX Sternal System Bone Plate
• Version Model Number: 24-STST-104
• 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	08806390884037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181806

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08806390884037]

Moist Heat or Steam Sterilization

[08806390884037]

Moist Heat or Steam Sterilization

[08806390884037]

Moist Heat or Steam Sterilization

[08806390884037]

Moist Heat or Steam Sterilization

[08806390884037]

Moist Heat or Steam Sterilization

[08806390884037]

Moist Heat or Steam Sterilization

[08806390884037]

Moist Heat or Steam Sterilization

[08806390884037]

Moist Heat or Steam Sterilization

[08806390884037]

Moist Heat or Steam Sterilization

[08806390884037]

Moist Heat or Steam Sterilization

[08806390884037]

Moist Heat or Steam Sterilization

[08806390884037]

Moist Heat or Steam Sterilization

[08806390884037]

Moist Heat or Steam Sterilization

[08806390884037]

Moist Heat or Steam Sterilization

[08806390884037]

Moist Heat or Steam Sterilization

[08806390884037]

Moist Heat or Steam Sterilization

[08806390884037]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-27
• Device Publish Date: 2023-09-19

On-Brand Devices [ARIX Sternal System Bone Plate]

• 08806390884037: 24-STST-104
• 08806390883931: 24-STST-120
• 08806390883924: 24-STST-108
• 08806390880428: 24-STST-106