AccessGUDID - DEVICE: Gold Lens (00855730007320)

GUDID

Device Identifier (DI) Information

Brand Name: Gold Lens
Version or Model: D101
Commercial Distribution Status: In Commercial Distribution
Catalog Number: D101
Company Name: DIAGNOSYS LLC

Primary DI Number: 00855730007320
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131488467 *Terms of Use

Device Description: Gold Lens (Adult): A non-sterile corneal electrode intended to be applied to the eye to detect the electrical response of the retina after a photic or other stimulus. It is typically in the form of a silver or gold electrode applied to the surface of the eye on or near the cornea. The general device that records this electrical activity is the electroretinograph (ERG).

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?
11460	Electroretinograph electrode	A non-sterile electrical conductor intended to be applied adjacent to the eye to transmit an electrical signal during an evaluation of the eye's retina. It is typically in the form of a conductive thread that is laid along the lower eyelid in contact with the tear film and cornea. The general device that records this electrical activity is the electroretinograph (ERG). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HLZ	Electrode, Corneal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K913239	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: 0f127b02-e567-46d8-987c-122bb9bf8dc1
Public Version Date: May 04, 2021
Public Version Number: 1
DI Record Publish Date: April 26, 2021