Procedure Pack Z8 510.700.112

GUDID 07640167751129

Procedure Pack Corneal Surgery 8.5

SIE AG, Surgical Instrument Engineering

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

• Primary Device ID: 07640167751129
• NIH Device Record Key: 92fb2aad-0b8d-43e9-a7e6-83cc93802b1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procedure Pack Z8
• Version Model Number: 8.5 CS Z8
• Catalog Number: 510.700.112
• Company DUNS: 482163628
• Company Name: SIE AG, Surgical Instrument Engineering
• 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: true
• 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

• Lumen/Inner Diameter: 8.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640167750580 [Primary]
GS1	07640167751129 [Package]; Contains: 07640167750580; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150323

FDA Product Code

• OOE: Ophthalmic Femtosecond Laser

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: 2019-11-08
• Device Publish Date: 2018-09-14

On-Brand Devices [Procedure Pack Z8]

• 07640167751167: Procedure Pack Corneal Surgery 9.5
• 07640167751105: Procedure Pack Corneal Surgery 9.0
• 07640167751129: Procedure Pack Corneal Surgery 8.5
• 07640167751143: Procedure Pack Corneal Surgery 10.5
• 07640167751082: Procedure Pack Corneal Surgery 10.0
• 07640167751068: Procedure Pack for Cataract Surgery
• 07640167751051: Procedure Pack Corneal Surgery Liquid
• 07640167751389: Procedure Pack Corneal Surgery Liquid SLIM
• 07640167751372: Procedure Pack Corneal Surgery 10.0 SLIM
• 07640167751365: Procedure Pack Corneal Surgery 9.5 SLIM
• 07640167751358: Procedure Pack Corneal Surgery 9.0 SLIM
• 07640167751341: Procedure Pack Corneal Surgery 8.5 SLIM
• 07640167751334: Procedure Pack for Cataract Surgery SLIM