ARIX Wrist System Bone Plate

GUDID 08806390809566

Jeil Medical Corporation

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

• Primary Device ID: 08806390809566
• NIH Device Record Key: 865f8c0c-e158-415e-b791-6f71f66e0e63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARIX Wrist System Bone Plate
• Version Model Number: 25V-DLUL-007-H2
• 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	08806390809566 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170705

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08806390809566]

Moist Heat or Steam Sterilization

[08806390809566]

Moist Heat or Steam Sterilization

[08806390809566]

Moist Heat or Steam Sterilization

[08806390809566]

Moist Heat or Steam Sterilization

[08806390809566]

Moist Heat or Steam Sterilization

[08806390809566]

Moist Heat or Steam Sterilization

[08806390809566]

Moist Heat or Steam Sterilization

[08806390809566]

Moist Heat or Steam Sterilization

[08806390809566]

Moist Heat or Steam Sterilization

[08806390809566]

Moist Heat or Steam Sterilization

[08806390809566]

Moist Heat or Steam Sterilization

[08806390809566]

Moist Heat or Steam Sterilization

[08806390809566]

Moist Heat or Steam Sterilization

[08806390809566]

Moist Heat or Steam Sterilization

[08806390809566]

Moist Heat or Steam Sterilization

[08806390809566]

Moist Heat or Steam Sterilization

[08806390809566]

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: 2017-04-11

On-Brand Devices [ARIX Wrist System Bone Plate]

• 08809282818899: 25-DLUL-108
• 08809282818882: 25-DLUL-008
• 08809282818875: 25-DLUL-106
• 08809282818868: 25-DLUL-006
• 08809282818851: 25-DVRA-211-R
• 08809282818844: 25-DVRA-209-R
• 08809282818837: 25-DVRA-111-R
• 08809282818820: 25-DVRA-109-R
• 08809282818790: 25-DVRA-211-L
• 08809282818783: 25-DVRA-209-L
• 08809282818776: 25-DVRA-111-L
• 08809282818769: 25-DVRA-109-L
• 08806390809962: 25-DVRA-312-R
• 08806390809955: 25-DVRA-312-L
• 08806390809948: 25-DVRA-310-R
• 08806390809931: 25-DVRA-310-L
• 08806390809924: 25-DVRA-212-R
• 08806390809917: 25-DVRA-212-L
• 08806390809900: 25-DVRA-112-R
• 08806390809894: 25-DVRA-112-L
• 08806390809887: 25-DVRA-011-R
• 08806390809870: 25-DVRA-011-L
• 08806390809863: 25-DVRA-009-R
• 08806390809856: 25-DVRA-009-L
• 08806390809849: 25-DLUL-107
• 08806390809832: 25-DLUL-105
• 08806390809825: 25-DLUL-007
• 08806390809818: 25-DLUL-005
• 08806390809139: 25-DVRA-110-R
• 08806390809122: 25-DVRA-110-L
• 08806390809115: 25-DVRA-210-R
• 08806390809108: 25-DVRA-210-L
• 08806390801409: 25-DVRA-311-R
• 08806390801393: 25-DVRA-311-L
• 08806390800266: 25-DVRA-309-R
• 08806390800259: 25-DVRA-309-L
• 08806390876858: 25R-DVRA-209-R
• 08806390876841: 25R-DVRA-209-L
• 08806390876834: 25R-DVRA-108-R
• 08806390876827: 25R-DVRA-108-L
• 08806390876810: 25J-DVRA-209-R
• 08806390876803: 25J-DVRA-209-L
• 08806390876797: 25J-DVRA-108-R
• 08806390876780: 25J-DVRA-108-L
• 08806390885522: 25R-DVRA-211-R
• 08806390885515: 25R-DVRA-211-L
• 08806390885508: 25R-DVRA-110-R
• 08806390885492: 25R-DVRA-110-L
• 08806390885485: 25J-DVRA-211-R
• 08806390885478: 25J-DVRA-211-L