Procedure Pack 510.700.106

GUDID 07640167750986

Procedure Pack Corneal Surgery Ø 8.5mm

SIE AG, Surgical Instrument Engineering

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

• Primary Device ID: 07640167750986
• NIH Device Record Key: 6e1265df-43ba-4dea-a2f9-286b39079f7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procedure Pack
• Version Model Number: 8.5 CS
• Catalog Number: 510.700.106
• 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	07640167750443 [Primary]
GS1	07640167750986 [Package]; Contains: 07640167750443; Package: Carton [10 Units]; In Commercial Distribution

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: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-09-14

On-Brand Devices [Procedure Pack]

• 07640167751044: Procedure Pack LASIK Ø 9.5mm
• 07640167751037: Procedure Pack LASIK Ø 9.0mm
• 07640167751020: Procedure Pack LASIK Ø 8.5mm
• 07640167751013: Procedure Pack LASIK Ø 10.0mm
• 07640167751006: Procedure Pack Corneal Surgery Ø 9.5mm
• 07640167750450: Procedure Pack Corneal Surgery Ø 9.0mm
• 07640167750986: Procedure Pack Corneal Surgery Ø 8.5mm
• 07640167750979: Procedure Pack Corneal Surgery Ø 10.0mm
• 07640167750962: Procedure Pack Advanced Corneal Surgery Ø 9.5mm
• 07640167750412: Procedure Pack Advanced Corneal Surgery Ø 9.0mm
• 07640167750948: Procedure Pack Advanced Corneal Surgery Ø 8.5mm
• 07640167750931: Procedure Pack Advanced Corneal Surgery Ø 10.0mm
• 07640167750894: Procedure Pack LCS Ø 9.5mm
• 07640167750887: Procedure Pack LCS Ø 9.0mm
• 07640167750870: Procedure Pack LCS Ø 8.5mm
• 07640167750863: Procedure Pack LCS Ø 10.0mm
• 07640167750788: Procedure Pack Ø 9.5mm, 90µm flap thickness
• 07640167750771: Procedure Pack Ø 9.5mm, 140µm flap thickness
• 07640167750764: Procedure Pack Ø 9.5mm, 110µm flap thickness
• 07640167750757: Procedure Pack Ø 9.5mm,100µm flap thickness
• 07640167750740: Procedure Pack Ø 9.0mm, 90µm flap thickness
• 07640167750733: Procedure Pack Ø 9.0mm, 140µm flap thickness
• 07640167750726: Procedure Pack Ø 9.0mm, 110µm flap thickness
• 07640167750719: Procedure Pack Ø 9.0mm,100µm flap thickness
• 07640167750702: Procedure Pack Ø 8.5mm, 90µm flap thickness
• 07640167750696: Procedure Pack Ø 8.5mm, 140µm flap thickness
• 07640167750689: Procedure Pack Ø 8.5mm,110µm flap thickness
• 07640167750672: Procedure Pack Ø 8.5mm,100µm flap thickness
• 07640167750665: Procedure Pack Ø 10.0mm, 90µm flap thickness
• 07640167750658: Procedure Pack Ø 10.0mm, 140µm flap thickness
• 07640167750641: Procedure Pack Ø 10.0mm, 110µm flap thickness
• 07640167750634: Procedure Pack 10.0 mm, 100um flap Thickness