T-Edge 10 AMS10-120-T

GUDID 07290110640651

Sterilizer,steam

TUTTNAUER ISRAEL LTD.

Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer

• Primary Device ID: 07290110640651
• NIH Device Record Key: 38e7d5ec-3768-4951-81aa-2af547500a67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T-Edge 10
• Version Model Number: T-Edge 10
• Catalog Number: AMS10-120-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	07290110640651 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-01-10
• Device Publish Date: 2020-11-16

On-Brand Devices [T-Edge 10 ]

• 07290110640446: Sterilizer, steam
• 07290110640651: Sterilizer,steam
• 07290110640644: Sterilizer,steam