Procedure Pack Z8

Basic Information

• Brand Name: Procedure Pack Z8
• Primary DI: 07640167751341
• Version / Model: 8.5 CS Z8 S
• Catalog Number: 510.700.120
• Company Name: SIE AG, Surgical Instrument Engineering
• Labeler DUNS: 482163628
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-22
• Public Version: 1
• Public Version Date: 2020-12-30
• Public Version Status: New
• Public Device Record Key: 11c023e6-1a33-4b71-9fde-80bb1e5905d1

Device Description

Procedure Pack Corneal Surgery 8.5 SLIM

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	886.4390	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45150	Ophthalmic surgical procedure kit, non-medicated, single-use	A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640167751341	GS1
Package	07640167751280	GS1	carton	10	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K150323	000

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	8.5	Millimeter