ri-scope® L ophtalmoscope head L2 LED 3,5 V 10571-203

GUDID 04045396182196

The Riester ophthalmoscope is produced for the examination of the eye and the eyeground. .

Rudolf Riester GmbH

Direct ophthalmoscope, battery-powered
Primary Device ID04045396182196
NIH Device Record Key4d0d150f-4c27-4e37-9d1a-210c6242b1e1
Commercial Distribution StatusIn Commercial Distribution
Brand Nameri-scope® L ophtalmoscope head L2 LED 3,5 V
Version Model Number10571-203
Catalog Number10571-203
Company DUNS537208717
Company NameRudolf Riester GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104045396182196 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ERAOtoscope

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-05
Device Publish Date2021-01-28

Devices Manufactured by Rudolf Riester GmbH

04045396007017 - Pack of 6 pcs. ri-pen® red2021-07-27 The Riester diagnostic light is used for ophthalmological examination.
04045396120310 - ri-pen® blue2021-07-27 The Riester diagnostic light is used for ophthalmological examination.
04045396120341 - ri-pen® green2021-07-27 The Riester diagnostic light is used for ophthalmological examination.
04045396120389 - ri-pen® silver2021-07-27 The Riester diagnostic light is used for ophthalmological examination.
04045396120464 - ri-pen® black2021-07-27 The Riester diagnostic light is used for ophthalmological examination.
04045396120525 - ri-pen® red2021-07-27 The Riester diagnostic light is used for ophthalmological examination.
04045396198487 - e-xam XL 2.5 V, black2021-07-27 The Riester diagnostic light is used for examination.
04045396198562 - Pack of 6 pcs. ri-pen®, violett2021-07-27 The Riester diagnostic light is used for ophthalmological examination.

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