AccessGUDID - DEVICE: ri-former® diagnostic station, mobile, 2-handles, with big-ben, 3.5V/230V (04045396189188)

GUDID

Device Identifier (DI) Information

Brand Name: ri-former® diagnostic station, mobile, 2-handles, with big-ben, 3.5V/230V
Version or Model: 3652-600
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3652-600
Company Name: Rudolf Riester GmbH

Primary DI Number: 04045396189188
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 537208717 *Terms of Use

Device Description: Diagnostic stations for diagnostic ENT instrument heads for non-invasive diagnosis.

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?
11585	ENT examination/treatment system	An assembly of devices intended to support a patient in a supine or reclining position and provide specialized features for an ear/nose/throat (ENT) examination or treatment. It typically includes a table and/or chair and functional components such as a suction/blowing apparatus, equipment drawers, and a mirror heater.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HLJ	Ophthalmoscope, Battery-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K950914	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: 8e662220-6da4-4d9e-82e9-375f93ea0a7b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 31, 2016