AccessGUDID - DEVICE: ri-scope® retinoscope head slit XL 3.5 V, (04045396129931)

GUDID

Device Identifier (DI) Information

Brand Name: ri-scope® retinoscope head slit XL 3.5 V,
Version or Model: 10544-301
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10544-301
Company Name: Rudolf Riester GmbH

Primary DI Number: 04045396129931
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 537208717 *Terms of Use

Device Description: The slit/spot retinoscopes (also known as skiascopes) are produced to determine the refraction (ametropias) of the eye.

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?
32712	Retinoscope, battery-powered	A battery-powered, hand-held, ophthalmic instrument that is used to measure the refractive errors of the eye through the projection of a beam of light into the eye, and the observation of the movement of the illuminated area on the retinal surface and of the refraction of the emergent rays. The batteries may be of the rechargeable type, and are housed within the handle of the instrument. Also known as a skiascope and the method as sciascopy.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HKM	Retinoscope, Battery-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K964338	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: b386d14e-efd3-479d-b714-4cd873d1b5a7
Public Version Date: February 05, 2021
Public Version Number: 1
DI Record Publish Date: January 28, 2021