ri-scope® L ophthalmoscope L2 LED 2,5V, AA handle

Primary DI
04045396182431
Brand
ri-scope® L ophthalmoscope L2 LED 2,5V, AA handle
Company
Rudolf Riester GmbH
Model
3729-203
Catalog number
3729-203
Device description
The Riester ophthalmoscope is produced for the examination of the eye and the eyeground.
Published
2021-01-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ERAOtoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERAOtoscopeEar, Nose, Throat1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K932506000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K932506000RI-SCOPE (S)Rudolf Riester GmbH & Co. KG1993-10-08ERA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04045396182431PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04045396182431040453961824314045396182431

GMDN Terms#

Term, Definition table
TermDefinition
Direct ophthalmoscope, battery-poweredA battery-powered, hand-held, ophthalmic instrument designed to examine the interior of the eye allowing the examiner to clearly see the details of the retina and other structures/media (cornea, aqueous, lens, and vitreous). It consists of a built-in light source that is directed by the examiner through the pupil to illuminate the interior of the eyeball, a mirror with a single view hole, and a dial containing several lenses of different powers that can be alternated by the examiner while viewing. It produces an upright, or unreversed, image of about 15 times magnification. Batteries are housed in the instrument’s handle; supplemental devices (e.g., spare light bulbs) may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
537208717
Device count
1
Lot or batch
true
Manufacturing date on label
true

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