ZeptoLinnk IOL Positioning System Z2023

GUDID B560Z20230

Disposable Handpiece

MYNOSYS CELLULAR DEVICES, INC.

Electrosurgical handpiece, single-use

• Primary Device ID: B560Z20230
• NIH Device Record Key: 7711df53-b786-4054-ad95-5402ccbb0b15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZeptoLinnk IOL Positioning System
• Version Model Number: Z2023
• Catalog Number: Z2023
• Company DUNS: 827036927
• Company Name: MYNOSYS CELLULAR DEVICES, INC.
• 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: 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: 7604565015
• Email: nhartman@centricityvision.com
• Phone: 7604565015
• Email: nhartman@centricityvision.com
• Phone: 7604565015
• Email: nhartman@centricityvision.com
• Phone: 7604565015
• Email: nhartman@centricityvision.com
• Phone: 7604565015
• Email: nhartman@centricityvision.com
• Phone: 7604565015
• Email: nhartman@centricityvision.com
• Phone: 7604565015
• Email: nhartman@centricityvision.com
• Phone: 7604565015
• Email: nhartman@centricityvision.com
• Phone: 7604565015
• Email: nhartman@centricityvision.com
• Phone: 7604565015
• Email: nhartman@centricityvision.com
• Phone: 7604565015
• Email: nhartman@centricityvision.com
• Phone: 7604565015
• Email: nhartman@centricityvision.com
• Phone: 7604565015
• Email: nhartman@centricityvision.com
• Phone: 7604565015
• Email: nhartman@centricityvision.com
• Phone: 7604565015
• Email: nhartman@centricityvision.com
• Phone: 7604565015
• Email: nhartman@centricityvision.com
• Phone: 7604565015
• Email: nhartman@centricityvision.com
• Phone: 7604565015
• Email: nhartman@centricityvision.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B560Z20230 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223763

FDA Product Code

• PUL: Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-26
• Device Publish Date: 2023-06-16

On-Brand Devices [ZeptoLinnk IOL Positioning System]

• B560Z20240: Disposable Handpiece (Plus)
• B560Z20230: Disposable Handpiece