FDA.reportPublic FDA data

RM Electrode - 10 pack

Primary DI
00860012396139
Brand
RM Electrode - 10 pack
Company
Retmap, Inc.
Model
RMH 25-01
Device description
Ten units of disposable corneal contact lens electrode used for measurement and recording of full field electroretinography (ffERG) and multi-focal ERG (mfERG) signals.
Published
2026-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HLZElectrode, Corneal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLZElectrode, CornealOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253586000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253586000RM Electrode (RMH 25-01)Retmap, Inc.2026-04-01HLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860012396139PrimaryGS10
00860012396122Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012396139008600123961398600123961390860012396139
00860012396122008600123961228600123961220860012396122

GMDN Terms#

Term, Definition table
TermDefinition
Electroretinograph electrodeA 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.

Regulatory Flags#

DUNS number
963712646
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860012396115RM Electrode - 10 packRMH 23-012024-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860012396115RM Electrode - 10 packRetmap, Inc.HLZ2024-12-09
00855730007429DTL 2DIAGNOSYS LLCHLZ2024-11-11
10855730007426DTL 2DIAGNOSYS LLCHLZ2024-11-11
00855730007320Gold LensDIAGNOSYS LLCHLZ2021-04-26
00855730007337Gold LensDIAGNOSYS LLCHLZ2021-04-26
00850594007011DTLDIAGNOSYS LLCHLZ2016-08-29
EFABF062ERG-JetFabrinal SAHLZ2016-08-10
EFABF061ERG-JetFabrinal SAHLZ2016-08-10