econom® Vac. 2.7 V / XL 2.5 V, C-handle - The Riester otoscope has been produced with - Rudolf Riester GmbH

Duns Number:537208717

Device Description: The Riester otoscope has been produced with examination of the auditory canal in mind, com The Riester otoscope has been produced with examination of the auditory canal in mind, combined with a Riester ear speculum.The Riester ophthalmoscope has been designed for the examination of the eye and its background.

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More Product Details

Catalog Number

2050

Brand Name

econom® Vac. 2.7 V / XL 2.5 V, C-handle

Version/Model Number

2050

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K925754

Product Code Details

Product Code

HLJ

Product Code Name

Ophthalmoscope, Battery-Powered

Device Record Status

Public Device Record Key

d01d4244-6964-454e-9517-e8b2df4d0c6e

Public Version Date

February 05, 2021

Public Version Number

1

DI Record Publish Date

January 28, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RUDOLF RIESTER GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 282
2 A medical device with a moderate to high risk that requires special controls. 332