FDA.reportPublic FDA data

Bernell

Primary DI
B945BC1275VF0
Brand
Bernell
Company
Bernell
Model
BC1275VF
Catalog number
BC1275VF
Device description
Vergence Facility Prism Flipper 12D BO Range 3D BI Range (6PD and 1.5PD Prisms)
Published
2026-05-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B945BC1275VF0PrimaryHIBCC0

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.

Regulatory Flags#

DUNS number
175947340
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B945BC10420BernellBC1042BC10422026-05-02
B945BC10440BernellBC1044BC10442026-05-02
B945BC12701000BernellBC1270100BC12701002026-05-03
B945BC1270100NI0BernellBC1270100NIBC1270100NI2026-05-03
B945BC12701250BernellBC1270125BC12701252026-05-03
B945BC1270125NI0BernellBC1270125NIBC1270125NI2026-05-03
B945BC12701500BernellBC1270150BC12701502026-05-03
B945BC1270150NI0BernellBC1270150NIBC1270150NI2026-05-03
B945BC12701750BernellBC1270175BC12701752026-05-03
B945BC1270175NI0BernellBC1270175NIBC1270175NI2026-05-03
B945BC12702000BernellBC1270200BC12702002026-05-03
B945BC1270200NI0BernellBC1270200NIBC1270200NI2026-05-03
B945BC12702250BernellBC1270225BC12702252026-05-03
B945BC1270225NI0BernellBC1270225NIBC1270225NI2026-05-03
B945BC1270250BernellBC127025BC1270252026-05-03
B945BC12702500BernellBC1270250BC12702502026-05-03
B945BC1270250NI0BernellBC1270250NIBC1270250NI2026-05-03
B945BC127025500BernellBC12702550BC127025502026-05-03
B945BC12702550NI0BernellBC12702550NIBC12702550NI2026-05-03
B945BC127025NI0BernellBC127025NIBC127025NI2026-05-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B945BC12701000BernellBernellHPB2026-05-03
B945BC1270100NI0BernellBernellHPB2026-05-03
B945BC12701250BernellBernellHPB2026-05-03
B945BC1270125NI0BernellBernellHPB2026-05-03
B945BC12701500BernellBernellHPB2026-05-03
B945BC1270150NI0BernellBernellHPB2026-05-03
B945BC12701750BernellBernellHPB2026-05-03
B945BC1270175NI0BernellBernellHPB2026-05-03
B945BC12702000BernellBernellHPB2026-05-03
B945BC1270200NI0BernellBernellHPB2026-05-03
B945BC12702250BernellBernellHPB2026-05-03
B945BC1270225NI0BernellBernellHPB2026-05-03
B945BC1270250BernellBernellHPB2026-05-03
B945BC12702500BernellBernellHPB2026-05-03
B945BC1270250NI0BernellBernellHPB2026-05-03
B945BC127025500BernellBernellHPB2026-05-03
B945BC12702550NI0BernellBernellHPB2026-05-03
B945BC127025NI0BernellBernellHPB2026-05-03
B945BC12702750BernellBernellHPB2026-05-03
B945BC1270275NI0BernellBernellHPB2026-05-03
B945BC12703000BernellBernellHPB2026-05-03
B945BC1270300NI0BernellBernellHPB2026-05-03
B945BC12703250BernellBernellHPB2026-05-03
B945BC1270325NI0BernellBernellHPB2026-05-03
B945BC12703500BernellBernellHPB2026-05-03
B945BC1270350NI0BernellBernellHPB2026-05-03
B945BC12703750BernellBernellHPB2026-05-03
B945BC1270375NI0BernellBernellHPB2026-05-03
B945BC12704000BernellBernellHPB2026-05-03
B945BC1270400NI0BernellBernellHPB2026-05-03