FDA.reportPublic FDA data

Bernell

Primary DI
B945MIT2U0
Brand
Bernell
Company
Bernell
Model
MIT2U
Catalog number
MIT2U
Device description
Macula Integrity Tester Version II - Unit only with Blue Filter Slide
Published
2026-05-02
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
HIYBrush, Haidinger, (Including Macular Integrity)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIYBrush, Haidinger, (Including Macular Integrity)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B945MIT2U0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Haidinger brush imagerA mains electricity (AC-powered) ophthalmic device designed to produce an image consisting of two conical brush-like images with apexes touching (known as Haidinger brushes). The observation of the image characteristics by a patient through a Nicole prism facilitates his/her visual function evaluation, particularly the macular integrity.

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
B945BC10420BernellBernellHIY2026-05-02
B945BC10440BernellBernellHIY2026-05-02
B945BC675C0BernellBernellHIY2026-05-02
B945BC675INC0BernellBernellHIY2026-05-02
B945MIT20BernellBernellHIY2026-05-02
B945BC10350BernellBernellHIY2026-04-30
B945BC10410BernellBernellHIY2026-04-30
00840159900208RumexRUMEX INTERNATIONAL CORP.HIY2020-06-09
00840159900215RumexRUMEX INTERNATIONAL CORP.HIY2020-06-09