SIM-LASIK Pack 510.701.012

GUDID 07640167750368

SIM-LASIK Pack 200 µm flap, Ø 8.5 mm

SIE AG, Surgical Instrument Engineering

Ophthalmic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 07640167750368
• NIH Device Record Key: 74c6bcd8-8d14-43be-8816-df5ca6f92c70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIM-LASIK Pack
• Version Model Number: 8.5
• Catalog Number: 510.701.012
• Company DUNS: 482163628
• Company Name: SIE AG, Surgical Instrument Engineering
• 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 Dimensions

• Width: 8.5 Millimeter
• Width: 8.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640167750368 [Primary]
GS1	07640167750900 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112154

FDA Product Code

• HQF: Laser, Ophthalmic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-09-22

On-Brand Devices [SIM-LASIK Pack]

• 07640167750382: SIM-LASIK Pack 200 µm flap, Ø 9.5 mm
• 07640167750375: SIM-LASIK Pack 200 µm flap, Ø 9.0 mm
• 07640167750368: SIM-LASIK Pack 200 µm flap, Ø 8.5 mm