RM Electrode - 10 pack

Basic Information

• Brand Name: RM Electrode - 10 pack
• Primary DI: 00860012396115
• Version / Model: RMH 23-01
• Company Name: Retmap, Inc.
• Labeler DUNS: 963712646
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2024-12-09
• Public Version: 1
• Public Version Date: 2024-12-17
• Public Version Status: New
• Public Device Record Key: acfc763c-264b-409f-b8bf-ecd2722367c0

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HLZ	Electrode, Corneal	Ophthalmic	886.1220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860012396115	GS1
Unit of Use	00860012396108	GS1

Premarket Submissions

Submission Number	Supplement Number
K232273	000