HD LenZ Pack Plus, for ZEISS RESIGHT® 54019

GUDID 00856222004735

1 Each 54416 HD LenZ for ZEISS RESIGHT®, 1 Each 40417 Hassan-Tornambe Contact Lens, & 1 Each 51555 ZEISS RESIGHT® Microscope Head Cover Drape

OCULUS SURGICAL INC

Diagnostic condensing lens

• Primary Device ID: 00856222004735
• NIH Device Record Key: 6f57e85c-10f2-44ad-a51a-fccc54445357
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HD LenZ Pack Plus, for ZEISS RESIGHT®
• Version Model Number: 54019
• Catalog Number: 54019
• Company DUNS: 015409582
• Company Name: OCULUS SURGICAL 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7722362622
• Email: sales@oculussurgical.com
• Phone: 7722362622
• Email: sales@oculussurgical.com
• Phone: 7722362622
• Email: sales@oculussurgical.com
• Phone: 7722362622
• Email: sales@oculussurgical.com
• Phone: 7722362622
• Email: sales@oculussurgical.com
• Phone: 7722362622
• Email: sales@oculussurgical.com
• Phone: 7722362622
• Email: sales@oculussurgical.com
• Phone: 7722362622
• Email: sales@oculussurgical.com
• Phone: 7722362622
• Email: sales@oculussurgical.com
• Phone: 7722362622
• Email: sales@oculussurgical.com
• Phone: 7722362622
• Email: sales@oculussurgical.com
• Phone: 7722362622
• Email: sales@oculussurgical.com
• Phone: 7722362622
• Email: sales@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com
• Phone: 7722362622
• Email: info@oculussurgical.com

Device Dimensions

• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856222004728 [Primary]
GS1	00856222004735 [Package]; Contains: 00856222004728; Package: Case [8 Units]; In Commercial Distribution

FDA Product Code

• LRO: General Surgery Tray

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: 2020-12-02
• Device Publish Date: 2020-11-24

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• 00852475007172 - HD Disposable, LenZ: 2022-02-23 1 HD Disposable LenZ
• 00852475007219 - Versa Optic Set, for f=175mm: 2022-02-02 1 Versa Optic Set, for f=175mm
• 00852475007257 - Versa Optic Set, for f=200mm: 2022-02-02 1 Versa Optic Set, for f=200mm
• 10852475007209 - Contact Lens, HD Professional, Cohen-Benner, "CBC": 2021-03-08 1 Each 54013 Contact Lens, HD Professional, Cohen-Benner Contact "CBC"