ri-derma dermatoscope head LED 3.5 V, 10577-301

GUDID 04045396147171

The ri-derma dermascope is produced for early identification of changes of skin pigmentation (malignant melanomas).

Rudolf Riester GmbH

Dermatoscope, optical Dermatoscope, optical Dermatoscope, optical Dermatoscope, optical Dermatoscope, optical Dermatoscope, optical Dermatoscope, optical
Primary Device ID04045396147171
NIH Device Record Key7c8f0adf-095a-425c-af7f-59f65e32e51b
Commercial Distribution StatusIn Commercial Distribution
Brand Nameri-derma dermatoscope head LED 3.5 V,
Version Model Number10577-301
Catalog Number10577-301
Company DUNS537208717
Company NameRudolf Riester GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS104045396147171 [Primary]

FDA Product Code

FSPLoupe, Diagnostic/Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-27
Device Publish Date2021-07-19

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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