AccessGUDID - DEVICE: DRSplus (08053677040116)

GUDID

Device Identifier (DI) Information

Brand Name: DRSplus
Version or Model: DRSplus
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CENTERVUE SPA

Primary DI Number: 08053677040116
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338702316 *Terms of Use

Device Description: The CenterVue DRSplus is a confocal scanning ophthalmoscope indicated for color imaging of a human retina without the use of a mydriatic agent.

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
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?
10551	Ophthalmic fundus camera	An electrically-powered optical device intended to be used to create digital colour photographic images/video of the ocular fundus (interior eye surface opposite the lens) through the pupil, to aid in diagnosing and monitoring retinal pathology; it may also be used for images/video of the anterior chamber. The image/video is typically transferred to a computer for display on its screen and/or for storage in a database. This device is also known as a retinal camera.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MYC	Ophthalmoscope, Laser, Scanning

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K192113	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: 9d5fc72b-dbaa-4ad0-9e7f-9b1ea8eae888
Public Version Date: December 17, 2019
Public Version Number: 1
DI Record Publish Date: December 09, 2019