69150 69150-1A

GUDID 07290110640378

Sterilizer,steam

TUTTNAUER ISRAEL LTD.

Steam sterilizer

• Primary Device ID: 07290110640378
• NIH Device Record Key: 18f4ab7e-05a1-4de2-9677-4ad6cd8fedba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 69150
• Version Model Number: 69150-1A
• Catalog Number: 69150-1A
• 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	07290110640378 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063711

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

On-Brand Devices [69150]

• 07290110640378: Sterilizer,steam
• 07290110640309: Sterilizer,steam