ARIX Ankle System Bone Plate

GUDID 08800089434343

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 08800089434343
• NIH Device Record Key: 7fabcc51-5599-443d-92e8-c20ae354106b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARIX Ankle System Bone Plate
• Version Model Number: 35V-DLF3-008-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	08800089434343 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231441

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08800089434343]

Moist Heat or Steam Sterilization

[08800089434343]

Moist Heat or Steam Sterilization

[08800089434343]

Moist Heat or Steam Sterilization

[08800089434343]

Moist Heat or Steam Sterilization

[08800089434343]

Moist Heat or Steam Sterilization

[08800089434343]

Moist Heat or Steam Sterilization

[08800089434343]

Moist Heat or Steam Sterilization

[08800089434343]

Moist Heat or Steam Sterilization

[08800089434343]

Moist Heat or Steam Sterilization

[08800089434343]

Moist Heat or Steam Sterilization

[08800089434343]

Moist Heat or Steam Sterilization

[08800089434343]

Moist Heat or Steam Sterilization

[08800089434343]

Moist Heat or Steam Sterilization

[08800089434343]

Moist Heat or Steam Sterilization

[08800089434343]

Moist Heat or Steam Sterilization

[08800089434343]

Moist Heat or Steam Sterilization

[08800089434343]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-01
• Device Publish Date: 2023-07-24

On-Brand Devices [ARIX Ankle System Bone Plate]

• 08806390874274: 35V-DLF2-008-L
• 08806390874267: 35V-DLF2-007-L
• 08806390874250: 35V-DLF2-006-L
• 08806390874243: 35V-DLF2-005-L
• 08806390874236: 35V-DLF2-004-L
• 08806390874229: 35V-DLF2-003-L
• 08806390874212: 35V-DLF2-008-R
• 08806390874205: 35V-DLF2-007-R
• 08806390874199: 35V-DLF2-006-R
• 08806390874182: 35V-DLF2-005-R
• 08806390874175: 35V-DLF2-004-R
• 08806390874168: 35V-DLF2-003-R
• 08800089434343: 35V-DLF3-008-R
• 08800089434336: 35V-DLF3-008-L
• 08800089434329: 35V-DLF3-007-R
• 08800089434312: 35V-DLF3-007-L
• 08800089434305: 35V-DLF3-006-R
• 08800089434299: 35V-DLF3-006-L
• 08800089434282: 35V-DLF3-005-R
• 08800089434275: 35V-DLF3-005-L
• 08800089434268: 35V-DLF3-004-R
• 08800089434251: 35V-DLF3-004-L
• 08800089434244: 35V-DLF3-003-R
• 08800089434237: 35V-DLF3-003-L
• 08806390801430: 35-DLST-009
• 08806390800204: 35-DLST-010
• 08806390800181: 35-DLST-008
• 08806390800174: 35-DLST-007
• 08806390800167: 35-DLST-006
• 08806390800150: 35-DLST-005
• 08806390800143: 35-DLST-004
• 08806390800136: 35-DLST-003
• 08806390800129: 35-DLFI-008-R
• 08806390800112: 35-DLFI-007-R
• 08806390800105: 35-DLFI-006-R
• 08806390800099: 35-DLFI-005-R
• 08806390800082: 35-DLFI-004-R
• 08806390800075: 35-DLFI-003-R
• 08806390800068: 35-DLFI-008-L
• 08806390800051: 35-DLFI-007-L
• 08806390800044: 35-DLFI-006-L
• 08806390800037: 35-DLFI-005-L
• 08806390800020: 35-DLFI-004-L
• 08806390800013: 35-DLFI-003-L