FDA.reportPublic FDA data

Remidio

Primary DI
08906096520045
Brand
Remidio
Company
REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITED
Model
PSL - D20
Catalog number
3231680018
Device description
Remidio Portable Slit Lamp (PSL-D20) is a handheld digital device for anterior segment screening & diagnosis of the human eye. High-resolution images obtained with advanced optics and using iPhone’s latest technology. User-friendly iOS enhances the imaging technology and the Remidio patient management application enable the user to view, save, archive, edit and retrieve the captured Anterior Images using a built im-age archival database.
Published
2021-11-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HJOBiomicroscope, Slit-Lamp, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJOBiomicroscope, Slit-Lamp, Ac-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08906096520045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08906096520045089060965200458906096520045

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic slit lamp, examinationA mains electricity (AC-powered), ophthalmic, binocular microscope designed to examine the interior anatomy of the eye (anterior and posterior surfaces) by viewing through the iris. It produces a narrow slit of powerful light which is projected into the eye, and resulting light reflections are detected obliquely with a travelling microscope to enable observation of the internal ocular surfaces. It is used to perform a variety of measurements [e.g., intraocular pressure (IOP) or tonometry, corneal thickness, anterior chamber depth] and to evaluate symptoms (e.g., eye itchiness, grittiness, pain, dry eyes, photophobia, and reduced visual acuity).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+917676759999contactus@remidio.com

Regulatory Flags#

DUNS number
650711448
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08906096520076RemidioINSTAREF R2010000100212023-07-06
08906096520083RemidioREM-90010100100052023-07-06
08906096520052RemidioRemidio FOP2022-01-31
08906096520069RemidioRemidio Connect2022-01-31
08906096520038RemidioMRD-106507114482021-11-26
08906096520021RemidioAIM32316800122020-02-19
08906096520014Remidio 0012019-02-03

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