AccessGUDID - DEVICE: ri-scope® L oto/opht. L2,LED/XL 3.5 V,incl 2 AA (04045396181694)

GUDID

Device Identifier (DI) Information

Brand Name: ri-scope® L oto/opht. L2,LED/XL 3.5 V,incl 2 AA
Version or Model: 3748.009
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3748.009
Company Name: Rudolf Riester GmbH

Primary DI Number: 04045396181694
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 537208717 *Terms of Use

Device Description: The Riester otoscope is produced for illumination and examination of the auditory canal in combination with Riester ear specula The Riester ophthalmoscope is produced for the examination of the eye and the eyeground.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45084	Ophthalmic/otologic diagnostic set	A collection of battery-powered devices intended to be used by a physician to perform an ophthalmic and/or otoscopic clinical examination on a patient. The devices are typically enclosed in a dedicated case and will typically include an ophthalmoscope and an otoscope, a dedicated interchangeable handle that contains the batteries which may be rechargeable and common to these examination devices, spare parts (e.g., extra ear specula, light bulbs) 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ERA	Otoscope

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K932506	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6e8552dc-8706-48fd-aef1-e3a177b1073b
Public Version Date: February 05, 2021
Public Version Number: 1
DI Record Publish Date: January 28, 2021