Identity
- Trade Name
- MedCare Visions EUDAMEDFDA UDI
- Generic Name
- Subdermal needle electrode FDA UDI
- Device Name
- Disposable Sterile EEG Subdermal Needle Electrode EUDAMEDDisposable OL4162056 1-channel aEEG Needle Electrode Set, 12mm x29ga, 40", (20) FDA UDI
- Model / Reference
- PRO-ERY EUDAMEDFDA UDIOL4162056 EUDAMED
- Description
- Disposable OL4162056 1-channel aEEG Needle Electrode Set, 12mm x29ga, 40", (20) FDA UDI
Identifiers
- Catalog Number
- OL4162056 FDA UDI
- Primary DI / UDI-DI
- 00816022023602 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00816022023602 EUDAMED
- 510(k) Number
- K020910 FDA UDI
- FDA Product Code
- GXZ FDA UDI
- EMDN Code
- N01010202 EEG EXTRACRANIC ELECTRODES EUDAMED
- GMDN Term
- Subdermal needle electrode FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1350 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Category: Subdermal needle electrode
MedCare Visions by Impulse Medical Technologies, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Subdermal needle electrode.
- Rhythmlink® — Rhythmlink International, LLC · Class II
- Neuroline Twisted Pair SubdermalNeurology Needle Electrodes — Ambu A/S · Class II
- Horizon™ — Advantage Medical Electronics, LLC · Class II
- Neuroradium — Technomed Engineering B.V. · Class II
- Sphenoidal Electrode Set — Ad-Tech Medical Instrument Corp. · Class II
- Spinal Electrode Kit — Ad-Tech Medical Instrument Corp. · Class II
- Horizon™ — Advantage Medical Electronics, LLC · Class II
- Neuroline SubdermalNeurology Needle Electrodes — Ambu A/S · Class II
Cleared under the same submission
K020910 also covers:
- MedCare Visions — IMPULSE MEDICAL TECHNOLOGIES, INC.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Impulse Medical Technologies, Inc.
Sources (2)
- FDA UDI 0a355e60-332d-4cac-ac74-69ebef9d5e5a 35 fields · synced Jul 29, 2026
- EUDAMED 1c8a0575-b01a-4403-bf33-e8aa77f89c2e 61 fields · synced Jul 29, 2026