FDA.reportPublic FDA data

Bernell

Primary DI
B945TOM1800
Brand
Bernell
Company
Bernell
Model
TOM180
Catalog number
TOM180
Device description
Skiascopic Lens Rack (Wooden) Bamboo Case
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
HMHRack, Skiascopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMHRack, SkiascopicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B945TOM1800PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vision corrective trial lensA non-patient-contact ophthalmic trial lens, or set of trial lenses of various dioptric powers, intended for vision testing to determine the required refraction for vision correction. This device may be used in conjunction with a phoropter (not included).

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
B945CBAR40BernellBernellHMH2026-05-02
B945DSLRS80BernellBernellHMH2026-05-02
B945HTLRPS0BernellBernellHMH2026-05-02
B945L1220840BernellBernellHMH2026-05-02
B091151600Retinoscopy Rack with CompassGulden Ophthalmics Inc.HMH2023-07-05
B091151610Retinoscopy RackGulden Ophthalmics Inc.HMH2023-07-05
03664188000220VisionixLUNEAU TECHNOLOGY OPERATIONSHMH2023-06-08
06945033901211TIANNUO / TNMEDLianyungang Tiannuo Optical Instrument Co., Ltd.HMH2018-09-24
06945033901235TIANNUO / TNMEDLianyungang Tiannuo Optical Instrument Co., Ltd.HMH2018-09-24