Identity
- Trade Name
- THERMOGARD PLUS ABC EUDAMEDFDA UDI
- Generic Name
- Electrosurgical return electrode, single-use FDA UDI
- Device Name
- Non-orthopedic, Active, Dispersive Electrode, Gel EUDAMEDTHERMOGARD PLUS ABC PEDIATRIC DUAL DISPERSIVE ELECTRODE FDA UDI
- Model / Reference
- 7-383 EUDAMEDFDA UDI
- Description
- THERMOGARD PLUS ABC PEDIATRIC DUAL DISPERSIVE ELECTRODE FDA UDI
Identifiers
- Catalog Number
- 7-383 FDA UDI
- Primary DI / UDI-DI
- 10653405013761 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10653405013761 EUDAMED
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K02010202 ELECTROSURGERY DUAL PATIENT PADS (NEUTRAL ELECTRODES), SINGLE-USE EUDAMED
- GMDN Term
- Electrosurgical return electrode, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Category: Electrosurgical return electrode, single-use
Thermogard Plus Abc by Conmed Corporation — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10653405013761 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
- EUDAMED SRN
- US-MF-000012663
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED cf9f151d-f762-4815-bd2c-e11a8cae50af 61 fields · synced May 30, 2026
- FDA UDI 0d23cf2e-9c21-46fd-aec1-4a1eecc54e9b 36 fields · synced May 30, 2026