AccessGUDID - DEVICE: ri-scope® F.O. tongue blade holder LED 3.5 V, (04045396147140)

GUDID

Device Identifier (DI) Information

Brand Name: ri-scope® F.O. tongue blade holder LED 3.5 V,
Version or Model: 10574-301
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10574-301
Company Name: Rudolf Riester GmbH

Primary DI Number: 04045396147140
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 537208717 *Terms of Use

Device Description: The blade holder is produced for examination of the oral cavity and pharynx in combination with commercial wooden and plastic blades.

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?
45085	ENT diagnostic set	A collection of battery-powered devices intended to be used by a physician to perform an ear/nose/throat (ENT) clinical examination on a patient. The devices are typically enclosed in a dedicated case and may include an ophthalmoscope, an otoscope, a pharyngoscope, a dedicated interchangeable handle that contains the batteries, which may be rechargeable and common to all the examination devices, different attachments (e.g., ear specula, mirrors, tongue depressors), spare parts (e.g., light bulbs), and 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 [?]
K950913	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: 58af332a-26df-4852-a96f-78029b712431
Public Version Date: February 05, 2021
Public Version Number: 1
DI Record Publish Date: January 28, 2021