Identity
- Trade Name
- 9021S0235 FDA UDI
- Generic Name
- Analytical non-scalp cutaneous electrode FDA UDI
- Device Name
- 9021S0235 Surface Electrodes FDA UDI
- Model / Reference
- 71002-SC/AP/12 FDA UDI
- Description
- 9021S0235 Surface Electrodes FDA UDI
Identifiers
- Catalog Number
- 71002-SC/AP/12 FDA UDI
- Primary DI / UDI-DI
- 05707480038251 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Analytical non-scalp cutaneous electrode FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 20 Centimeter FDA UDI
Category: Analytical non-scalp cutaneous electrode
9021s0235 by Ambu A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Analytical non-scalp cutaneous electrode.
- Rhythmlink® — Rhythmlink International, LLC · Class II
- Rhythmlink® — Rhythmlink International, LLC · Class II
- SENTIO — Medos International Sàrl · Class II
- Neuroguard — Technomed Engineering B.V. · Class II
- Sense System with IBT Electrodes — Infinite Biomedical Technologies LLC · Class II
- Alpha — WillowWood Global LLC · Class II
- Alpha — WillowWood Global LLC · Class II
- Alpha — WillowWood Global LLC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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
- Ambu A/S
Sources (1)
- FDA UDI 4080a2cf-86f5-4f16-af47-28972391b4fc 37 fields · synced Jun 8, 2026