ri-scope® F.O. light conductor LED 3.5 V,

Primary DI
04045396147164
Brand
ri-scope® F.O. light conductor LED 3.5 V,
Company
Rudolf Riester GmbH
Model
10576-301
Catalog number
10576-301
Device description
For the illumination of the field of investigation.
Published
2021-01-28
Public version status
New
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
K950913000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K950913000PERFECT, ENT SET, PRAKTIKANT, DE LUXERudolf Riester GmbH & Co. KG1995-05-12ERA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04045396147164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04045396147164040453961471644045396147164

GMDN Terms#

Term, Definition table
TermDefinition
ENT diagnostic setA collection of battery-powered devices intended to be used by a physician to perform an ear/nose/throat (ENT) clinical examination on a patient. The devices are typically enclosed in a dedicated case and may include an ophthalmoscope, an otoscope, a pharyngoscope, a dedicated interchangeable handle that contains the batteries, which may be rechargeable and common to all the examination devices, different attachments (e.g., ear specula, mirrors, tongue depressors), spare parts (e.g., light bulbs), and 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
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04045396195387Stethoscope duplex® 2.0 white,4200-024200-022021-01-28
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