Contact Lens, HD Professional, Cohen-Benner, "CBC" 54013

GUDID 10852475007209

1 Each 54013 Contact Lens, HD Professional, Cohen-Benner Contact "CBC"

OCULUS SURGICAL INC

Vitrectomy contact lens, single-use

• Primary Device ID: 10852475007209
• NIH Device Record Key: 258d8ed9-0a8e-40db-9d03-0a0aa0e89799
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Contact Lens, HD Professional, Cohen-Benner, "CBC"
• Version Model Number: 54013
• Catalog Number: 54013
• 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: false
• 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: 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: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter
• Outer Diameter: 13.6 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 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	00852475007202 [Primary]
GS1	10852475007209 [Package]; Contains: 00852475007202; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051630

FDA Product Code

• HJK: Lens, Contact, Polymethylmethacrylate, Diagnostic

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: 2021-03-08
• Device Publish Date: 2021-02-26

Devices Manufactured by OCULUS SURGICAL INC

• 10856222004206 - SUPER VIEW Lens, Disposable Contact, Tornambe: 2024-08-21 SUPER VIEW Tornambe Disposable Contact Lens for use visualizing the fundus during vitreo-retinal surgery.
• 00852475007134 - BIOM Optic Set, HD Professional, for f=175mm: 2022-02-23 1 BIOM Optic Set, HD Professional, for f=175mm
• 10852475007148 - BIOM Optic Set, HD Professional, for f=200mm: 2022-02-23 1 BIOM Optic Set, HD Professional, for f=200mm
• 00852475007158 - BIOM Optic Set, HD Flex: 2022-02-23 1 BIOM Optic Set, HD Flex
• 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": 2021-03-081 Each 54013 Contact Lens, HD Professional, Cohen-Benner Contact "CBC"
• 10852475007209 - Contact Lens, HD Professional, Cohen-Benner, "CBC": 2021-03-08 1 Each 54013 Contact Lens, HD Professional, Cohen-Benner Contact "CBC"