FDA.reportPublic FDA data

Diagnostix™

Primary DI
00634782091200
Brand
Diagnostix™
Company
AMERICAN DIAGNOSTIC CORP
Model
5680B-56XEU
Catalog number
5680B-56XEU
Device description
Adstation Oto+-X/Coax Oph-L,Derm/Throat-X, EU
Published
2018-02-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HLJOphthalmoscope, Battery-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLJOphthalmoscope, Battery-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00634782091200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00634782091200006347820912006347820912000634782091200

GMDN Terms#

Term, Definition table
TermDefinition
Dermatoscope, opticalAn electrically-powered, hand-held instrument intended to be used for the direct microscopic examination of the external skin layers. The device has a built-in light source and magnification system that provides the user with the visualization of the structures of the epidermis and epidermal-dermal junction during dermatoscopy (also known as dermascopy). Oil may be applied to the skin to enhance skin transparency. This device is commonly used for the examination of skin structures and to assess abnormal colour and pattern changes of pigmented skin lesions (e.g., spongy birth marks, malignant melanoma).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
108999095
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00634782902636Adcuff™ 920-011N920-011N2026-02-23
00634782101695ADC®381N381N2026-02-20
00634782903213ADC®380N380N2026-02-20
00634782903190Advantage™611561152025-11-24
00634782903152Advantage™611261122025-09-19
00634782903169Advantage™612161212025-09-19
00634782903176Advantage™6121SA6121SA2025-09-19
00634782903183Advantage™6121X6121X2025-09-19
00634782903091Adtemp™ 424N-40424N-402025-02-05
00634782603106Adtemp™ 424N-200424N-2002025-02-05
00634782903039Adtemp™ 424N424N2025-01-29
00634782600402Adscope®608LPST608LPST2023-01-11
00634782600600Adscope®600IMCA600IMCA2023-01-10
00634782600617Adscope®600IST600IST2023-01-10
00634782600624Adscope®601IMCA601IMCA2023-01-10
00634782600631Adscope®601IST601IST2023-01-10
00634782600648Adscope®601RGBK601RGBK2023-01-10
00634782600655Adscope®608RGBK608RGBK2023-01-10
00634782600662Adscope®608RGW608RGW2023-01-10
00634782600679Adscope®606RGBK606RGBK2023-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16972545090024JeashiaZhejiang Honsun Medical Technology Co., Ltd.HLJ2026-02-03
06972545090133JeashiaZhejiang Honsun Medical Technology Co., Ltd.HLJ2026-02-02
00732094357929Welch Allyn, Inc.WELCH ALLYN, INC.HLJ2025-11-25
04053755202966BETA X OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGHLJ2025-07-17
00732094357936Welch Allyn, Inc.WELCH ALLYN, INC.HLJ2025-03-27
00732094357943Welch Allyn, Inc.WELCH ALLYN, INC.HLJ2025-03-27
10193489136241MEDLINEMEDLINE INDUSTRIES, INC.HLJ2024-11-28
10193489136210MEDLINEMEDLINE INDUSTRIES, INC.HLJ2024-09-09
00810149097515R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-08-28
04053755202232K 180 LED OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGHLJ2024-06-27
00850038195335Eli EzerU.S. OPHTHALMIC, L.L.C.HLJ2024-04-03
00850038195342Eli EzerU.S. OPHTHALMIC, L.L.C.HLJ2024-04-03
00810149090684R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149090745R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149090837R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149091056R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149091148R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149092039R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149093630R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149093647R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149094637R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149094644R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00634782601669Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2023-12-15
04030155000392EUROLIGHT E30, 2.5V ophthalmoscope with clic-closureKirchner & Wilhelm GmbH + Co KGHLJ2023-09-04
04030155001542BASIC-SET COMBILIGHT C10/E10 ophthalmoscope and otoscopeKirchner & Wilhelm GmbH + Co KGHLJ2023-09-04
04053755120000BETA 200 S OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGHLJ2022-12-15
04053755120017K 180 OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGHLJ2022-12-15
04053755119981BETA 200 OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGHLJ2022-12-12
00733657274714ADSTATION OTO LED/OPH COAX LED W/SPECALIMED, INC.HLJ2022-12-01
00732094347074Welch Allyn, Inc.WELCH ALLYN, INC.HLJ2022-08-05