EZ9PLUS-P EZ9PLUS-P

GUDID 07290110640040

0729011064004

TUTTNAUER ISRAEL LTD.

Steam sterilizer

• Primary Device ID: 07290110640040
• NIH Device Record Key: 47af1f80-00bd-4dc4-8022-15f17a9e3120
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EZ9PLUS-P
• Version Model Number: EZ9PLUS-P
• Catalog Number: EZ9PLUS-P
• Company DUNS: 600030209
• Company Name: TUTTNAUER ISRAEL LTD.
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290110640040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111736

FDA Product Code

• FLE: Sterilizer, Steam

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-17
• Device Publish Date: 2018-09-16

Devices Manufactured by TUTTNAUER ISRAEL LTD.

• 07290110640606 - TIVA2 TD: 2023-06-28 High level Disinfector
• 07290110640613 - TIVA2-H TD: 2023-06-28 High Level Disinfector
• 07290110640880 - TIVA10-1V-HS-MD: 2023-06-28 High Level Disinfector
• 07290110640897 - TIVA10-2V-HS-MD: 2023-06-28 High Level Disinfector
• 07290110642013 - TIVA8-MD: 2023-06-28 High Level Didinfector
• 05060474070003 - Model T-Classic: 2022-11-30 Sterilizer ,steam
• 07290110640644 - T-Edge 10: 2022-01-10 Sterilizer,steam
• 07290110640651 - T-Edge 10: 2022-01-10 Sterilizer,steam