ARIX Ankle Distal Tibia System Bone Plate

GUDID 08806390883412

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 08806390883412
• NIH Device Record Key: 8336abe6-22a3-4d33-a47a-39fc0e8ab771
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARIX Ankle Distal Tibia System Bone Plate
• Version Model Number: 35-DMTB-004-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	08806390883412 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202912

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08806390883412]

Moist Heat or Steam Sterilization

[08806390883412]

Moist Heat or Steam Sterilization

[08806390883412]

Moist Heat or Steam Sterilization

[08806390883412]

Moist Heat or Steam Sterilization

[08806390883412]

Moist Heat or Steam Sterilization

[08806390883412]

Moist Heat or Steam Sterilization

[08806390883412]

Moist Heat or Steam Sterilization

[08806390883412]

Moist Heat or Steam Sterilization

[08806390883412]

Moist Heat or Steam Sterilization

[08806390883412]

Moist Heat or Steam Sterilization

[08806390883412]

Moist Heat or Steam Sterilization

[08806390883412]

Moist Heat or Steam Sterilization

[08806390883412]

Moist Heat or Steam Sterilization

[08806390883412]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-07
• Device Publish Date: 2020-11-27

On-Brand Devices [ARIX Ankle Distal Tibia System Bone Plate]

• 08806390883467: 35-DMTB-010-L
• 08806390883450: 35-DMTB-008-R
• 08806390883443: 35-DMTB-008-L
• 08806390883436: 35-DMTB-006-R
• 08806390883429: 35-DMTB-006-L
• 08806390883412: 35-DMTB-004-R
• 08806390883405: 35-DMTB-004-L
• 08806390883399: 35-DMTB-003-R
• 08806390883382: 35-DMTB-003-L
• 08806390883375: 35-DLTB-010-R
• 08806390883368: 35-DLTB-010-L
• 08806390883351: 35-DLTB-008-R
• 08806390883344: 35-DLTB-008-L
• 08806390883337: 35-DLTB-006-R
• 08806390883320: 35-DLTB-006-L
• 08806390883313: 35-DLTB-004-R
• 08806390883306: 35-DLTB-004-L
• 08806390883290: 35-DLTB-003-R
• 08806390883283: 35-DLTB-003-L
• 08806390883474: 35-DMTB-010-R
• 08800089403820: 35-DMTB-014-R
• 08800089403813: 35-DMTB-014-L
• 08800089403806: 35-DMTB-012-R
• 08800089403790: 35-DMTB-012-L
• 08800089436484: 50-AAFU-008-R
• 08800089436477: 50-AAFU-008-L
• 08800089403165: 50-AAFU-108-R
• 08800089403158: 50-AAFU-108-L