ARIX Diaphysis System Bone Plate

GUDID 08806390850407

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 08806390850407
• NIH Device Record Key: e8b96f8d-8043-44ec-9581-6d2a1a230377
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARIX Diaphysis System Bone Plate
• Version Model Number: 35-DIST-210
• 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	08806390850407 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171285

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08806390850407]

Moist Heat or Steam Sterilization

[08806390850407]

Moist Heat or Steam Sterilization

[08806390850407]

Moist Heat or Steam Sterilization

[08806390850407]

Moist Heat or Steam Sterilization

[08806390850407]

Moist Heat or Steam Sterilization

[08806390850407]

Moist Heat or Steam Sterilization

[08806390850407]

Moist Heat or Steam Sterilization

[08806390850407]

Moist Heat or Steam Sterilization

[08806390850407]

Moist Heat or Steam Sterilization

[08806390850407]

Moist Heat or Steam Sterilization

[08806390850407]

Moist Heat or Steam Sterilization

[08806390850407]

Moist Heat or Steam Sterilization

[08806390850407]

Moist Heat or Steam Sterilization

[08806390850407]

Moist Heat or Steam Sterilization

[08806390850407]

Moist Heat or Steam Sterilization

[08806390850407]

Moist Heat or Steam Sterilization

[08806390850407]

Moist Heat or Steam Sterilization

[08806390850407]

Moist Heat or Steam Sterilization

[08806390850407]

Moist Heat or Steam Sterilization

[08806390850407]

Moist Heat or Steam Sterilization

[08806390850407]

Moist Heat or Steam Sterilization

[08806390850407]

Moist Heat or Steam Sterilization

[08806390850407]

Moist Heat or Steam Sterilization

[08806390850407]

Moist Heat or Steam Sterilization

[08806390850407]

Moist Heat or Steam Sterilization

[08806390850407]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2024-06-04
• Device Publish Date: 2017-09-01

On-Brand Devices [ARIX Diaphysis System Bone Plate]

• 08806390850483: 35V-DIST-116
• 08806390850476: 35V-DIST-114
• 08806390850469: 35V-DIST-112
• 08806390850452: 35V-DIST-110
• 08806390850445: 35V-DIST-108
• 08806390850438: 35V-DIST-106
• 08806390850421: 35-DIST-212
• 08806390850414: 35-DIST-211
• 08806390850407: 35-DIST-210
• 08806390850391: 35-DIST-209
• 08806390850384: 35-DIST-208
• 08806390850377: 35-DIST-207
• 08806390850360: 35-DIST-206
• 08806390850353: 35V-DIST-312
• 08806390850346: 35V-DIST-311
• 08806390850339: 35V-DIST-310
• 08806390850322: 35V-DIST-309
• 08806390850315: 35V-DIST-308
• 08806390850308: 35V-DIST-307
• 08806390850292: 35V-DIST-306
• 08806390850285: 35V-DIST-305
• 08806390850278: 35V-DIST-304