AccessGUDID - DEVICE: BETA 200 LED RETINOSCOPE (04053755191673)

GUDID

Device Identifier (DI) Information

Brand Name: BETA 200 LED RETINOSCOPE
Version or Model: 000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C-008.15.353
Company Name: Heine Optotechnik GmbH & Co. KG

Primary DI Number: 04053755191673
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315274563 *Terms of Use

Device Description: 3,5 V

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 [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: ae00e680-189a-4260-9edc-64d014442b90
Public Version Date: July 17, 2024
Public Version Number: 2
DI Record Publish Date: December 12, 2022