T-Edge 10 AMS10-230-T

GUDID 07290110640439

Sterilizer, steam

TUTTNAUER ISRAEL LTD.

Steam sterilizer

• Primary Device ID: 07290110640439
• NIH Device Record Key: f55431b5-0ac5-4e0a-b332-a4222119d791
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T-Edge 10
• Version Model Number: T-Edge 10
• Catalog Number: AMS10-230-T
• 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	07290110640439 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143311

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: 2019-12-05
• Device Publish Date: 2019-11-27

Devices Manufactured by TUTTNAUER ISRAEL LTD.

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• 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