Z5-TL Z5-TL-5008

GUDID 07640166768944

Implant + TP-SNS + BL-HC

Z-Systems AG

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• Primary Device ID: 07640166768944
• NIH Device Record Key: 49aa8b41-4a69-4bd3-a84c-ec6e779fc7d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Z5-TL
• Version Model Number: Z5-TL-5008
• Catalog Number: Z5-TL-5008
• Company DUNS: 483189556
• Company Name: Z-Systems AG
• 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: true
• 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: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com

Device Dimensions

• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640166768944 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201712

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-20
• Device Publish Date: 2024-02-12

On-Brand Devices [Z5-TL]

• 07640166768968: Implant + TP-SNS + BL-HC
• 07640166768951: Implant + TP-SNS + BL-HC
• 07640166768944: Implant + TP-SNS + BL-HC
• 07640166768937: Implant + TP-SNS + BL-HC
• 07640166768920: Implant + TP-SNS + BL-HC
• 07640166768913: Implant + TP-SNS + BL-HC