ri-scope® L F.O. otoscope L3 LED 3.5 V, C-handle 3704.002

GUDID 04045396181328

The Riester otoscope is produced for illumination and examination of the auditory canal in combination with Riester ear specula

Rudolf Riester GmbH

Otoscope, direct
Primary Device ID04045396181328
NIH Device Record Keycfe56bbc-7202-40af-96bd-94f130ef61db
Commercial Distribution StatusIn Commercial Distribution
Brand Nameri-scope® L F.O. otoscope L3 LED 3.5 V, C-handle
Version Model Number3704.002
Catalog Number3704.002
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
GS104045396181328 [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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