Z5_Tray_Box Z5_Tray_Box

GUDID 07640166761761

Surgical Box

Z-Systems AG

Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable

• Primary Device ID: 07640166761761
• NIH Device Record Key: 0344eee7-6787-4933-bfd7-2097c22b2e32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Z5_Tray_Box
• Version Model Number: Z5_Tray_Box
• Catalog Number: Z5_Tray_Box
• 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: 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640166761761 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201878

FDA Product Code

• KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

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

[07640166761761]

Moist Heat or Steam Sterilization

[07640166761761]

Moist Heat or Steam Sterilization

[07640166761761]

Moist Heat or Steam Sterilization

[07640166761761]

Moist Heat or Steam Sterilization

[07640166761761]

Moist Heat or Steam Sterilization

[07640166761761]

Moist Heat or Steam Sterilization

[07640166761761]

Moist Heat or Steam Sterilization

[07640166761761]

Moist Heat or Steam Sterilization

[07640166761761]

Moist Heat or Steam Sterilization

[07640166761761]

Moist Heat or Steam Sterilization

[07640166761761]

Moist Heat or Steam Sterilization

[07640166761761]

Moist Heat or Steam Sterilization

[07640166761761]

Moist Heat or Steam Sterilization

[07640166761761]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-12
• Device Publish Date: 2024-04-04

Devices Manufactured by Z-Systems AG

• 07640166769491 - Z5m: 2024-04-19 Monotype root-form dental implant made of Zirconia Familiy Z5m Size Z5m-36-10
• 07640166760870 - BL-OSC-H: 2024-04-15 Ceramic Basal Screw, incl. single-use screwdriver
• 07640166764700 - BL-OST-H: 2024-04-15 Titanium basal screw, including single-use screwdriver
• 07640166760863 - BL-OST: 2024-04-12 Basal Screw
• 07640166761747 - Z5_m_c_mt leer: 2024-04-12 Surgical Tray Z5_m_c_mt_empty
• 07640166761754 - Z5_m_c_mt Inlay: 2024-04-12 Surgical Inlay Z5_m_c_mt
• 07640166761761 - Z5_Tray_Box: 2024-04-12Surgical Box
• 07640166761761 - Z5_Tray_Box: 2024-04-12 Surgical Box
• 07640166761778 - Z5_m_c_mt Tray FULL: 2024-04-12 Surgical Tray Z5_m_c_mt full