ZeptoLink IOL Positioning System C2023

GUDID B560C20230

Power Console

MYNOSYS CELLULAR DEVICES, INC.

Electrosurgical handpiece, single-use

• Primary Device ID: B560C20230
• NIH Device Record Key: e7a1b4d0-f1d0-4310-b149-6db0f4eec250
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZeptoLink IOL Positioning System
• Version Model Number: C2023
• Catalog Number: C2023
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	B560C20230 [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: false

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

Devices Manufactured by MYNOSYS CELLULAR DEVICES, INC.

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• B560Z20240 - ZeptoLinnk IOL Positioning System: 2023-06-26 Disposable Handpiece (Plus)
• B560C20200 - ZEPTO Precision Capsulotomy System: 2021-12-01 Power Console
• B560Z20200 - ZEPTO Precision Capsulotomy System: 2021-12-01 ZEPTO Disposable Handpiece with Fluid Isolator
• B560124300 - Zepto Capsulotomy System: 2018-03-29 Zepto Handpiece
• B560126840 - Zepto Capsulotomy System: 2018-03-29 Zepto Power Console
• B560126860 - Zepto Capsulotomy System: 2018-03-29 Zepto Fluid Isolator with Roller Dispenser