HD LenZ Pack for ZEISS RESIGHT® 54010

GUDID 00852475007110

1 Each 54416 HD LenZ for ZEISS RESIGHT® & 1 Each 40417 Hassan-Tornambe Contact Lens

OCULUS SURGICAL INC

Vitrectomy contact lens, single-use
Primary Device ID00852475007110
NIH Device Record Keye26e5521-73b2-4a54-850b-34433063eaef
Commercial Distribution StatusIn Commercial Distribution
Brand NameHD LenZ Pack for ZEISS RESIGHT®
Version Model Number54010
Catalog Number54010
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 Latextrue
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
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

Device Dimensions

Outer Diameter13 Millimeter
Outer Diameter18 Millimeter
Outer Diameter13 Millimeter
Outer Diameter18 Millimeter
Outer Diameter13 Millimeter
Outer Diameter18 Millimeter
Outer Diameter13 Millimeter
Outer Diameter18 Millimeter
Outer Diameter13 Millimeter
Outer Diameter18 Millimeter
Outer Diameter13 Millimeter
Outer Diameter18 Millimeter
Outer Diameter13 Millimeter
Outer Diameter18 Millimeter
Outer Diameter13 Millimeter
Outer Diameter18 Millimeter
Outer Diameter13 Millimeter
Outer Diameter18 Millimeter
Outer Diameter13 Millimeter
Outer Diameter18 Millimeter
Outer Diameter13 Millimeter
Outer Diameter18 Millimeter
Outer Diameter13 Millimeter
Outer Diameter18 Millimeter
Outer Diameter13 Millimeter
Outer Diameter18 Millimeter
Outer Diameter13 Millimeter
Outer Diameter18 Millimeter
Outer Diameter13 Millimeter
Outer Diameter18 Millimeter
Outer Diameter13 Millimeter
Outer Diameter18 Millimeter
Outer Diameter13 Millimeter
Outer Diameter18 Millimeter
Outer Diameter13 Millimeter
Outer Diameter18 Millimeter
Outer Diameter13 Millimeter
Outer Diameter18 Millimeter
Outer Diameter13 Millimeter
Outer Diameter18 Millimeter
Outer Diameter13 Millimeter
Outer Diameter18 Millimeter
Outer Diameter13 Millimeter
Outer Diameter18 Millimeter
Outer Diameter13 Millimeter
Outer Diameter18 Millimeter
Outer Diameter13 Millimeter
Outer Diameter18 Millimeter
Outer Diameter13 Millimeter
Outer Diameter18 Millimeter
Outer Diameter13 Millimeter
Outer Diameter18 Millimeter
Outer Diameter13 Millimeter
Outer Diameter18 Millimeter
Outer Diameter13 Millimeter
Outer Diameter18 Millimeter
Outer Diameter13 Millimeter
Outer Diameter18 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
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
GS100852475007103 [Primary]
GS100852475007110 [Package]
Contains: 00852475007103
Package: Case [12 Units]
In Commercial Distribution

FDA Product Code

LROGeneral Surgery Tray

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-02
Device Publish Date2020-11-24

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"2021-03-08 1 Each 54013 Contact Lens, HD Professional, Cohen-Benner Contact "CBC"
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.