FDA.reportPublic FDA data

Optego

Primary DI
00360843010575
Brand
Optego
Company
Optego Vision USA Inc.
Model
936912
Device description
Prism Block with handle, 12 Diopter
Published
2023-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HKWPrism, Bar, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKWPrism, Bar, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00360843010575PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00360843010575003608430105753608430105750360843010575

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic ophthalmic prismA transparent geometrical device intended to use light refraction principles to assist in the diagnosis of visual problems, especially those associated with ocular muscles (e.g., reduced convergence or accommodation). It is available in various forms such as a bar with multiple prisms of graduated powers, or a single prism on a handle. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
835541145
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00360843006523Optego978369-Optego2023-11-10
00360843006530Optego978369-Optego2023-11-10
00360843009395Optego978362023-11-10
00360843010964Optego98343062024-07-24
00360843010971Optego9827032024-07-24
00360843009142Optego983432024-02-01
00360843009340Optego982702024-01-12
00360843006912Optego9835602024-02-01
00360843006929Optego9835612024-02-01
00360843007247Optego982752024-02-01
00360843009135Optego983392024-02-01
00360843010698Optego983152024-02-01
00360843009364Optego982732024-01-12
00360843007940Optego942882024-01-11
00360843007957Optego942892024-01-11
00360843007964Optego942902024-01-11
00360843007971Optego942912024-01-11
00360843007988Optego942922024-01-11
00360843007995Optego942932024-01-11
00360843008008Optego942942024-01-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00360843010469OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010476OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010483OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010490OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010506OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010513OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010520OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010537OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010544OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010551OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010568OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010582OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010599OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010605OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010612OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010629OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010636OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010643OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010650OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010667OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010674OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010681OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010230OptegoOptego Vision USA Inc.HKW2023-11-01
00360843010247OptegoOptego Vision USA Inc.HKW2023-11-01
00360843010254OptegoOptego Vision USA Inc.HKW2023-11-01
00360843010261OptegoOptego Vision USA Inc.HKW2023-11-01
00360843010278OptegoOptego Vision USA Inc.HKW2023-11-01
00360843010285OptegoOptego Vision USA Inc.HKW2023-11-01
00360843010292OptegoOptego Vision USA Inc.HKW2023-11-01
00360843010308OptegoOptego Vision USA Inc.HKW2023-11-01