AccessGUDID - DEVICE: RM Electrode - 10 pack (00860012396115)

GUDID

Device Identifier (DI) Information

Brand Name: RM Electrode - 10 pack
Version or Model: RMH 23-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Retmap, Inc.

Primary DI Number: 00860012396115
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 963712646 *Terms of Use

Device Description: Ten units of disposable corneal contact lens electrode used for measurement and recording of full field electroretinography (ERG) signals.

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:	Yes
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?
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 [?]
K232273	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: acfc763c-264b-409f-b8bf-ecd2722367c0
Public Version Date: December 17, 2024
Public Version Number: 1
DI Record Publish Date: December 09, 2024