Bone Fixation Screw Kit

GUDID 08806390852135

Jeil Medical Corporation

Craniofacial fixation plate kit, non-bioabsorbable

• Primary Device ID: 08806390852135
• NIH Device Record Key: 264e8d5d-77e1-4d5e-949a-bc33fcf30aa0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bone Fixation Screw Kit
• Version Model Number: 112-080 KIT
• 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: false
• 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	08806390852135 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050669

FDA Product Code

• DZL: Screw, Fixation, Intraosseous

Sterilization

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

[08806390852135]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-06-19
• Device Publish Date: 2017-07-25

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• 08800089444687 - ARIX System Bone Screw: 2024-11-25
• 08800089442904 - Xpine Spinal Fixation System: 2024-11-22
• 08800089442911 - Xpine Spinal Fixation System: 2024-11-22
• 08800089442928 - Xpine Spinal Fixation System: 2024-11-22