HD Disposable, LenZ 54026

GUDID 00852475007172

1 HD Disposable LenZ

OCULUS SURGICAL INC

Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens
Primary Device ID00852475007172
NIH Device Record Key263cd793-10d7-4b59-b055-5af06133bdce
Commercial Distribution StatusIn Commercial Distribution
Brand NameHD Disposable, LenZ
Version Model Number54026
Catalog Number54026
Company DUNS015409582
Company NameOCULUS SURGICAL INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Device Dimensions

Outer Diameter18 Millimeter
Outer Diameter18 Millimeter
Outer Diameter18 Millimeter
Outer Diameter18 Millimeter
Outer Diameter18 Millimeter
Outer Diameter18 Millimeter
Outer Diameter18 Millimeter
Outer Diameter18 Millimeter
Outer Diameter18 Millimeter
Outer Diameter18 Millimeter
Outer Diameter18 Millimeter
Outer Diameter18 Millimeter
Outer Diameter18 Millimeter
Outer Diameter18 Millimeter
Outer Diameter18 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100852475007165 [Primary]
GS100852475007172 [Package]
Contains: 00852475007165
Package: Case [12 Units]
In Commercial Distribution

FDA Product Code

HJLLens, Condensing, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-23
Device Publish Date2022-02-15

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00852475007158 - BIOM Optic Set, HD Flex2022-02-23 1 BIOM Optic Set, HD Flex
00852475007172 - HD Disposable, LenZ2022-02-231 HD Disposable LenZ
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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"
00852475007271 - VERSA HD Disposable LenZ2020-12-14 1 VERSA HD Disposable LenZ
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