FDA.reportPublic FDA data

Bernell

Primary DI
B945MFLIPP6000
Brand
Bernell
Company
Bernell
Model
MFLIP+6.00
Catalog number
MFLIP+6.00
Device description
Monocular Flipper +6.00D
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
B945MFLIPP6000PrimaryHIBCC0

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