ARIX Small Fragment System

GUDID 08800089404100

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 08800089404100
• NIH Device Record Key: cc95b943-ec94-4f25-94ef-46a930a7c916
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARIX Small Fragment System
• Version Model Number: 25-SFST-008
• 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	08800089404100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221920

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

[08800089404100]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-06
• Device Publish Date: 2022-08-29

On-Brand Devices [ARIX Small Fragment System]

• 08800089404186: 25-SFTS-112
• 08800089404179: 25-SFTS-108
• 08800089404162: 25-SFTS-010
• 08800089404155: 25-SFTS-008
• 08800089404148: 25-SFTR-014
• 08800089404131: 25-SFTR-012
• 08800089404124: 25-SFST-020
• 08800089404117: 25-SFST-010
• 08800089404100: 25-SFST-008
• 08800089404094: 25-SFST-006
• 08800089404087: 25-SFST-004