FDA.reportPublic FDA data

Optego

Primary DI
00360843007964
Brand
Optego
Company
Optego Vision USA Inc.
Model
94290
Device description
Optego® Prism Flipper, 5^in/10^out
Published
2024-01-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HPCSet, Lens, Trial, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HPCSet, Lens, Trial, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00360843007964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00360843007964003608430079643608430079640360843007964

GMDN Terms#

Term, Definition table
TermDefinition
Vision testing/training flipperA device in the form of flipper lenses (two lenses on either side of a rotatable stem) intended to be used for the diagnosis and treatment of ophthalmic accommodation disorders. It consists of binocular spherical plus/minus lenses that can quickly be flipped from plus to minus, and which can be used by a healthcare professional for diagnosis or by a patient for self-training. 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
00360843007971Optego942912024-01-11
00360843007988Optego942922024-01-11
00360843007995Optego942932024-01-11
00360843008008Optego942942024-01-11
00360843008015Optego942952024-01-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B945BC127680BernellBernellHPC2026-05-03
B945TLRSM0620BernellBernellHPC2026-05-03
B945TLRSM1000BernellBernellHPC2026-05-03
B945TLRSM10000BernellBernellHPC2026-05-03
B945TLRSM10500BernellBernellHPC2026-05-03
B945TLRSM11000BernellBernellHPC2026-05-03
B945TLRSM12000BernellBernellHPC2026-05-03
B945TLRSM1250BernellBernellHPC2026-05-03
B945TLRSM13000BernellBernellHPC2026-05-03
B945TLRSM14000BernellBernellHPC2026-05-03
B945TLRSM1500BernellBernellHPC2026-05-03
B945TLRSM15000BernellBernellHPC2026-05-03
B945TLRSM16000BernellBernellHPC2026-05-03
B945TLRSM1750BernellBernellHPC2026-05-03
B945TLRSM18000BernellBernellHPC2026-05-03
B945TLRSM2000BernellBernellHPC2026-05-03
B945TLRSM20000BernellBernellHPC2026-05-03
B945TLRSM2250BernellBernellHPC2026-05-03
B945TLRSM2500BernellBernellHPC2026-05-03
B945TLRSM2750BernellBernellHPC2026-05-03
B945TLRSM3000BernellBernellHPC2026-05-03
B945TLRSM3250BernellBernellHPC2026-05-03
B945TLRSM3500BernellBernellHPC2026-05-03
B945TLRSM3750BernellBernellHPC2026-05-03
B945TLRSM4000BernellBernellHPC2026-05-03
B945TLRSM4250BernellBernellHPC2026-05-03
B945TLRSM4500BernellBernellHPC2026-05-03
B945TLRSM4750BernellBernellHPC2026-05-03
B945TLRSM5000BernellBernellHPC2026-05-03
B945TLRSM5250BernellBernellHPC2026-05-03