Extra Long Fixation Screw Multi-Use Uni- Torx 43-500057XL

GUDID 10841307117919

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 10841307117919
• NIH Device Record Key: 7804cfcf-4354-455c-bf7c-6d30f7c08208
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Extra Long Fixation Screw Multi-Use Uni- Torx
• Version Model Number: 43-500057XL
• Catalog Number: 43-500057XL
• Company DUNS: 868856969
• Company Name: IMPLANT DIRECT SYBRON MANUFACTURING LLC
• Device Count: 2
• 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: false
• 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

Customer Support Contacts

• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841307117912 [Unit of Use]
GS1	10841307117919 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K904236

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

[10841307117919]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-10-02

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