AMADEUS 130.700.001

GUDID 07640167751211

SurePass sterile blade for AMADEUS

SIS AG, Surgical Instrument Systems

Keratome blade, single-use

• Primary Device ID: 07640167751211
• NIH Device Record Key: 75034bdf-7519-4d32-ae6c-c47588099818
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMADEUS
• Version Model Number: SurePass
• Catalog Number: 130.700.001
• Company DUNS: 480508261
• Company Name: SIS AG, Surgical Instrument Systems
• Device Count: 10
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8667084490
• Email: usa@ziemergroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640167751211 [Primary]
GS1	07640167751228 [Unit of Use]

FDA Product Code

• HNO: Keratome, Ac-Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-15

On-Brand Devices [AMADEUS]

• 07640167751211: SurePass sterile blade for AMADEUS
• 07640167751198: Sterile vacuum tube for AMADEUS