FDA.reportPublic FDA data

Proscope™ Dermascope

Primary DI
00634782053734
Brand
Proscope™ Dermascope
Company
AMERICAN DIAGNOSTIC CORP
Model
5312-4
Catalog number
5312-4
Device description
Lamp for 5312,
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IBJLight, Microscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IBJLight, MicroscopePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00634782553524PackageGS110Not in Commercial Distribution
00634782853525PackageGS110In Commercial Distribution
00634782053734PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00634782553524006347825535246347825535240634782553524
00634782853525006347828535256347828535250634782853525
00634782053734006347820537346347820537340634782053734

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic/otologic diagnostic setA collection of battery-powered devices intended to be used by a physician to perform an ophthalmic and/or otoscopic clinical examination on a patient. The devices are typically enclosed in a dedicated case and will typically include an ophthalmoscope and an otoscope, a dedicated interchangeable handle that contains the batteries which may be rechargeable and common to these examination devices, spare parts (e.g., extra ear specula, light bulbs) may include a line-powered charging station (e.g., desktop, wall-mounted) to house/charge these devices. This is a reusable device that may contain some disposable devices.

Contacts#

Phone, Email table
PhoneEmail
1-800-232-2670info@adctoday.com

Regulatory Flags#

DUNS number
108999095
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00634782102258Adscope®608CFST608CFST2026-06-02
00634782603045ADC54202542022026-03-31
00634782603052ADC54203542032026-03-31
00634782603069ADC54204542042026-03-31
00634782603076ADC54205542052026-03-31
00634782098384Adscope®603-04W603-04W2026-03-30
00634782100209Adscope®608-12COP608-12COP2026-03-30
00634782100216Adscope®608-12G608-12G2026-03-30
00634782100223Adscope®608-12I608-12I2026-03-30
00634782100230Adscope®608-12ST608-12ST2026-03-30
00634782100247Adscope®608-12MBK608-12MBK2026-03-30
00634782100254Adscope®608-12RGBK608-12RGBK2026-03-30
00634782100261Adscope®608-12RGW608-12RGW2026-03-30
00634782100834Adscope®608-12BK608-12BK2026-03-30
00634782101190Adscope®608-01MBK608-01MBK2026-03-30
00634782101299Adsoft®602-078BK1Q602-078BK1Q2026-03-30
00634782101305Adsoft®602-078PR1Q602-078PR1Q2026-03-30
00634782101312Adsoft®602-078TQ1Q602-078TQ1Q2026-03-30
00634782101329Adsoft®602-078G1Q602-078G1Q2026-03-30
00634782101336Adsoft®602-078Y1Q602-078Y1Q2026-03-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00664816005866LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2025-10-20
00664816005873LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2025-10-20
00664816005934LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2025-10-20
00664816005941LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2025-10-20
00664816005958LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2025-10-20
00664816005965LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2025-10-20
08052691050002NED-DP Nano Eye Device for Digital PathologyNTP NANO TECH PROJECTS SRLIBJ2024-11-11
08052691050019NED-DH Nano Eye Device for Digital HematologyNTP NANO TECH PROJECTS SRLIBJ2024-11-11
GYNXMI60000GynexGYNEX CORPORATIONIBJ2023-12-20
04260158450065FotoFinder medicamFotoFinder Systems GmbHIBJ2023-08-07
04260158450089FotoFinder leviacamFotoFinder Systems GmbHIBJ2023-08-07
00664816002391LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2023-06-27
00664816002407LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2023-06-27
00664816002414LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2023-06-27
00664816002421LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2023-06-27
00664816002759LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2023-06-27
00852728008864SEILER MEDICAL DIVISIONSEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATEDIBJ2023-03-02
00860009669192SEILER MEDICAL DIVISIONSEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATEDIBJ2023-03-02
00860010027707SEILER MEDICAL DIVISIONSEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATEDIBJ2023-03-02
00850147000094MoleScope LiteMetaOptima Technology IncIBJ2023-02-17
85014700009486MoleScope LiteMetaOptima Technology IncIBJ2023-02-17
00304040043400Henry ScheinHENRY SCHEIN, INC.IBJ2022-05-03
00304040043417Henry ScheinHENRY SCHEIN, INC.IBJ2022-05-03
00304040043424Henry ScheinHENRY SCHEIN, INC.IBJ2022-05-03
00304040043431Henry ScheinHENRY SCHEIN, INC.IBJ2022-05-03
00304040043448Henry ScheinHENRY SCHEIN, INC.IBJ2022-05-03
00664816000908LW Scientific, IncLW SCIENTIFIC, INC.IBJ2021-04-09
00664816000922LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2021-04-09
00664816000939LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2021-04-09
00664816000946LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2021-04-09