FDA.reportPublic FDA data

Diagnostix™

Primary DI
00634782578077
Brand
Diagnostix™
Company
AMERICAN DIAGNOSTIC CORP
Model
5413
Catalog number
5413
Device description
Diagnostix Portable Dermascope,3.5v, LED
Published
2016-09-21
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
FSPLoupe, Diagnostic/Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSPLoupe, Diagnostic/SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00634782578077PackageGS110In Commercial Distribution
00634782076702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00634782578077006347825780776347825780770634782578077
00634782076702006347820767026347820767020634782076702

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.

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
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
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00850036373384Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373391Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373407Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373414Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373421Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373438Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373445Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373452Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00723896025321TTL Easy Size 2.5X Loupes RedPRACTICON, INC.FSP2026-01-07
00723896025338TTL Easy Size 3.0X Loupes RedPRACTICON, INC.FSP2026-01-07
00723896025505TTL Easy Size 2.5X Loupes SilverPRACTICON, INC.FSP2026-01-07
00723896025512TTL Easy Size 3.0X Loupes SilverPRACTICON, INC.FSP2026-01-07
00723896030097TTL Easy Size 2.5X Loupes BlackPRACTICON, INC.FSP2026-01-07
00723896030103TTL Easy Size 3.0X Loupes BlackPRACTICON, INC.FSP2026-01-07
00850036373902ErgoZoom™ PlanoMETREX RESEARCH, LLCFSP2025-07-21
00850036373919ErgoZoom™ RxMETREX RESEARCH, LLCFSP2025-07-21
00850036373926ErgoZoom™ Plano - Dragonfly™METREX RESEARCH, LLCFSP2025-07-21
00850036373933ErgoZoom™ Rx - Dragonfly™METREX RESEARCH, LLCFSP2025-07-21
00810186670054Enova IlluminationEnova Illumination, Inc.FSP2025-05-28
00810186670061Enova IlluminationEnova Illumination, Inc.FSP2025-05-28
00810186670078Enova IlluminationEnova Illumination, Inc.FSP2025-05-28
00810186670085Enova IlluminationEnova Illumination, Inc.FSP2025-05-28
00810186670092Enova IlluminationEnova Illumination, Inc.FSP2025-05-28
00810186670108Enova IlluminationEnova Illumination, Inc.FSP2025-05-28
00810186670115Enova IlluminationEnova Illumination, Inc.FSP2025-05-28
00810186670122Enova IlluminationEnova Illumination, Inc.FSP2025-05-28
00615375010129Universal Flip - PlanoMETREX RESEARCH, LLCFSP2025-04-30
00615375010136Universal Flip - RxMETREX RESEARCH, LLCFSP2025-04-30
00615375014493Dragonfly™ - Headlight only - PlanoMETREX RESEARCH, LLCFSP2025-04-30