RM Electrode - 10 pack

Primary DI
00860012396115
Brand
RM Electrode - 10 pack
Company
Retmap, Inc.
Model
RMH 23-01
Device description
Ten units of disposable corneal contact lens electrode used for measurement and recording of full field electroretinography (ERG) signals.
Published
2024-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K232273000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232273000RM Electrode (RMH 23-01)Retmap, Inc.2023-12-07HLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860012396115PrimaryGS10
00860012396108Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012396115008600123961158600123961150860012396115
00860012396108008600123961088600123961080860012396108

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
963712646
Device count
10
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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