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 ID10852475007209
NIH Device Record Key258d8ed9-0a8e-40db-9d03-0a0aa0e89799
Commercial Distribution StatusIn Commercial Distribution
Brand NameContact Lens, HD Professional, Cohen-Benner, "CBC"
Version Model Number54013
Catalog Number54013
Company DUNS015409582
Company NameOCULUS SURGICAL INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7722362622
Emailsales@oculussurgical.com
Phone7722362622
Emailsales@oculussurgical.com
Phone7722362622
Emailsales@oculussurgical.com
Phone7722362622
Emailsales@oculussurgical.com
Phone7722362622
Emailsales@oculussurgical.com
Phone7722362622
Emailsales@oculussurgical.com
Phone7722362622
Emailsales@oculussurgical.com
Phone7722362622
Emailsales@oculussurgical.com
Phone7722362622
Emailsales@oculussurgical.com
Phone7722362622
Emailsales@oculussurgical.com
Phone7722362622
Emailsales@oculussurgical.com
Phone7722362622
Emailsales@oculussurgical.com
Phone7722362622
Emailinfo@oculussurgical.com
Phone7722362622
Emailinfo@oculussurgical.com
Phone7722362622
Emailinfo@oculussurgical.com
Phone7722362622
Emailinfo@oculussurgical.com
Phone7722362622
Emailinfo@oculussurgical.com
Phone7722362622
Emailinfo@oculussurgical.com
Phone7722362622
Emailinfo@oculussurgical.com
Phone7722362622
Emailinfo@oculussurgical.com
Phone7722362622
Emailinfo@oculussurgical.com
Phone7722362622
Emailinfo@oculussurgical.com
Phone7722362622
Emailinfo@oculussurgical.com
Phone7722362622
Emailinfo@oculussurgical.com
Phone7722362622
Emailinfo@oculussurgical.com
Phone7722362622
Emailinfo@oculussurgical.com
Phone7722362622
Emailinfo@oculussurgical.com
Phone7722362622
Emailinfo@oculussurgical.com
Phone7722362622
Emailinfo@oculussurgical.com
Phone7722362622
Emailinfo@oculussurgical.com
Phone7722362622
Emailinfo@oculussurgical.com
Phone7722362622
Emailinfo@oculussurgical.com
Phone7722362622
Emailinfo@oculussurgical.com
Phone7722362622
Emailinfo@oculussurgical.com
Phone7722362622
Emailinfo@oculussurgical.com
Phone7722362622
Emailinfo@oculussurgical.com
Phone7722362622
Emailinfo@oculussurgical.com
Phone7722362622
Emailinfo@oculussurgical.com
Phone7722362622
Emailinfo@oculussurgical.com
Phone7722362622
Emailinfo@oculussurgical.com
Phone7722362622
Emailinfo@oculussurgical.com
Phone7722362622
Emailinfo@oculussurgical.com
Phone7722362622
Emailinfo@oculussurgical.com
Phone7722362622
Emailinfo@oculussurgical.com

Device Dimensions

Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter
Outer Diameter13.6 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100852475007202 [Primary]
GS110852475007209 [Package]
Contains: 00852475007202
Package: Case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HJKLens, Contact, Polymethylmethacrylate, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-08
Device Publish Date2021-02-26

Devices Manufactured by OCULUS SURGICAL INC

10856222004206 - SUPER VIEW Lens, Disposable Contact, Tornambe2024-08-21 SUPER VIEW Tornambe Disposable Contact Lens for use visualizing the fundus during vitreo-retinal surgery.
00852475007134 - BIOM Optic Set, HD Professional, for f=175mm2022-02-23 1 BIOM Optic Set, HD Professional, for f=175mm
10852475007148 - BIOM Optic Set, HD Professional, for f=200mm2022-02-23 1 BIOM Optic Set, HD Professional, for f=200mm
00852475007158 - BIOM Optic Set, HD Flex2022-02-23 1 BIOM Optic Set, HD Flex
00852475007172 - HD Disposable, LenZ2022-02-23 1 HD Disposable LenZ
00852475007219 - Versa Optic Set, for f=175mm2022-02-02 1 Versa Optic Set, for f=175mm
00852475007257 - Versa Optic Set, for f=200mm2022-02-02 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"

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