← Back to catalogue

RM Electrode - 10 pack

FDA UDI

Class II (US FDA UDI)

by Retmap, Inc.

Identity

Trade Name
RM Electrode - 10 pack FDA UDI
Generic Name
Electroretinograph electrode FDA UDI
Device Name
Ten units of disposable corneal contact lens electrode used for measurement and recording of full field electroretinography (ERG) signals. FDA UDI
Model / Reference
RMH 23-01 FDA UDI
Description
Ten units of disposable corneal contact lens electrode used for measurement and recording of full field electroretinography (ERG) signals. FDA UDI

Identifiers

Primary DI / UDI-DI
00860012396115 FDA UDI
510(k) Number
K232273 FDA UDI
FDA Product Code
HLZ FDA UDI
GMDN Term
Electroretinograph electrode FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.1220 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electroretinograph electrode

RM Electrode - 10 pack by Retmap, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electroretinograph electrode.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Retmap, Inc.

Sources (1)

  • FDA UDI acfc763c-264b-409f-b8bf-ecd2722367c0 34 fields · synced Jun 8, 2026