FDA.reportPublic FDA data

Gonio Ready 200 for f=200mm

Primary DI
00852475007332
Brand
Gonio Ready 200 for f=200mm
Company
OCULUS SURGICAL INC
Model
53671
Catalog number
53671
Device description
1 Each 53671 Gonio Ready 200 for f=200mm
Published
2020-08-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HJLLens, Condensing, Diagnostic
HKSPrism, Gonioscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJLLens, Condensing, DiagnosticOphthalmic1
HKSPrism, GonioscopicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852475007332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852475007332008524750073328524750073320852475007332

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic condensing lensAn ophthalmic lens used in binocular indirect ophthalmoscopy (a procedure that produces an inverted or reversed direct magnified image of the eye) to focus reflected light from the fundus of the eye. Compared to direct ophthalmosocoy, the indirect method enables better viewing of the peripheral region of the fundus out to the ora serrata (serrated junction between the retina and the ciliary body).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
772-236-2622sales@oculussurgical.com
772-236-2622info@oculussurgical.com

Regulatory Flags#

DUNS number
015409582
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856222004025SUPER VIEW® Pack40211402112016-09-23
00856222004728HD LenZ Pack Plus, for ZEISS RESIGHT®54019540192020-11-24
00856222004018SUPER VIEW® Pack40213402132016-09-23
00856222004209SUPER VIEW Lens, Disposable Contact, Tornambe40413404132024-08-13
10856222004206SUPER VIEW Lens, Disposable Contact, Tornambe40413404132024-08-13
00852475007042SUPER VIEW® Lens Set, HD Plus, Disposable for ZEISS RESIGHT®40240402402020-11-24
00852475007103HD LenZ Pack for ZEISS RESIGHT®54010540102020-11-24
00852475007127BIOM Optic Set, HD Professional, for f=175mm54021540212022-02-15
00852475007141BIOM Optic Set, HD Professional, for f=200mm54022540222022-02-15
00852475007165HD Disposable, LenZ54026540262022-02-15
00852475007240Versa Optic Set, for f=200mm54212542122022-01-25
00852475007264VERSA HD Disposable LenZ542162020-12-04
00856222004056SUPER VIEW® Disposable Lens Set, Essential40403404032016-09-23
00856222004179SUPER VIEW® Disposable Lens Set, Pivot Plus40227402272016-09-23
00856222004544SUPER VIEW® Disposable HD Lens Set for RESIGHT®40220402202020-11-24
00856222004551SUPER VIEW Pack, HD, Disposable, for ZEISS RESIGHT®54018540182020-11-24
00856222004742SUPER VIEW® Disposable Lens Set, Pivot40223402232016-09-23
00852475007158BIOM Optic Set, HD Flex54025540252022-02-15
00852475007219Versa Optic Set, for f=175mm54211542112022-01-25
00852475007080Super View® Pack, Pivot Plus (40101+40227)40229402292020-11-24

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