SUPER VIEW Lens, Disposable Contact, Tornambe 40413

GUDID 10856222004206

SUPER VIEW Tornambe Disposable Contact Lens for use visualizing the fundus during vitreo-retinal surgery.

OCULUS SURGICAL INC

Vitrectomy contact lens, single-use
Primary Device ID10856222004206
NIH Device Record Key88308905-2722-441a-81b2-4e7fa4f71d1b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSUPER VIEW Lens, Disposable Contact, Tornambe
Version Model Number40413
Catalog Number40413
Company DUNS015409582
Company NameOCULUS SURGICAL INC
Device Count1
DM Exempttrue
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone772-236-2622
Emailinfo@oculussurgical.com
Phone772-236-2622
Emailinfo@oculussurgical.com
Phone772-236-2622
Emailinfo@oculussurgical.com
Phone772-236-2622
Emailinfo@oculussurgical.com
Phone772-236-2622
Emailinfo@oculussurgical.com
Phone772-236-2622
Emailinfo@oculussurgical.com
Phone772-236-2622
Emailinfo@oculussurgical.com
Phone772-236-2622
Emailinfo@oculussurgical.com
Phone772-236-2622
Emailinfo@oculussurgical.com
Phone772-236-2622
Emailinfo@oculussurgical.com
Phone772-236-2622
Emailinfo@oculussurgical.com
Phone772-236-2622
Emailinfo@oculussurgical.com
Phone772-236-2622
Emailinfo@oculussurgical.com
Phone772-236-2622
Emailinfo@oculussurgical.com
Phone772-236-2622
Emailinfo@oculussurgical.com
Phone772-236-2622
Emailinfo@oculussurgical.com
Phone772-236-2622
Emailinfo@oculussurgical.com

Device Dimensions

Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter

Operating and Storage Conditions

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
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100856222004209 [Primary]
GS110856222004206 [Package]
Contains: 00856222004209
Package: [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 Date2024-08-21
Device Publish Date2024-08-13

Devices Manufactured by OCULUS SURGICAL INC

10856222004206 - SUPER VIEW Lens, Disposable Contact, Tornambe2024-08-21SUPER VIEW Tornambe Disposable Contact Lens for use visualizing the fundus during vitreo-retinal surgery.
10856222004206 - SUPER VIEW Lens, Disposable Contact, Tornambe2024-08-21 SUPER VIEW Tornambe Disposable Contact Lens for use visualizing the fundus during vitreo-retinal surgery.
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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"2021-03-08 1 Each 54013 Contact Lens, HD Professional, Cohen-Benner Contact "CBC"

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