T-Edge 11 AMS11-230-T

GUDID 07290110640736

Sterilizer ,steam

TUTTNAUER ISRAEL LTD.

Steam sterilizer

• Primary Device ID: 07290110640736
• NIH Device Record Key: cc1c80ec-08a1-42e4-8e2b-4f744af6f3d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T-Edge 11
• Version Model Number: AMS11-230-T
• Catalog Number: AMS11-230-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	07290110640736 [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: 2021-06-15
• Device Publish Date: 2021-06-07

On-Brand Devices [T-Edge 11 ]

• 07290110640712: Sterilizer,steam
• 07290110640736: Sterilizer ,steam
• 07290110640729: Sterilizer,steam