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Thermogard
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 51-7410Ref 51-7310Ref 51-7810Ref 51-7710Ref CRA-SGP
Identity
- Trade Name
- THERMOGARD EUDAMEDFDA UDI
- Generic Name
- Electrosurgical return electrode, single-use FDA UDICirculating immune complex (CIC) IVD, reagent FDA UDI
- Device Name
- Non-orthopedic, Active, Dispersive Electrode, Gel EUDAMEDTHERMOGARD DUAL DISPERSIVE ELECTRODE, CONTACT QUALITY MONITOR FDA UDITHERMOGARD DUAL DISPERSIVE ELECTRODE FDA UDITHERMOGARD PEDIATRIC DUAL DISPERSIVE ELECTRODE, CONTACT QUALITY MONITOR FDA UDI
- Model / Reference
- 51-7410 EUDAMEDFDA UDI51-7310 EUDAMEDFDA UDI51-7810 EUDAMEDFDA UDI51-7710 EUDAMEDFDA UDICRA-SGP EUDAMEDFDA UDI
- Description
- THERMOGARD DUAL DISPERSIVE ELECTRODE, CONTACT QUALITY MONITOR FDA UDITHERMOGARD DUAL DISPERSIVE ELECTRODE FDA UDITHERMOGARD PEDIATRIC DUAL DISPERSIVE ELECTRODE, CONTACT QUALITY MONITOR FDA UDI
Identifiers
- Catalog Number
- 51-7410 FDA UDI51-7810 FDA UDICRA-SGP FDA UDI51-7710 FDA UDI51-7310 FDA UDI
- Primary DI / UDI-DI
- 10653405031260 EUDAMEDFDA UDI10653405007449 EUDAMEDFDA UDI10653405007494 EUDAMEDFDA UDI10653405007470 EUDAMEDFDA UDI20653405986581 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10653405031260 EUDAMEDB-10653405007449 EUDAMEDB-10653405007494 EUDAMEDB-10653405007470 EUDAMEDB-20653405986581 EUDAMED
- 510(k) Number
- K140658 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K02010202 ELECTROSURGERY DUAL PATIENT PADS (NEUTRAL ELECTRODES), SINGLE-USE EUDAMEDK02010201 ELECTROSURGERY SINGLE PATIENT PADS (NEUTRAL ELECTRODES), SINGLE-USE EUDAMED
- GMDN Term
- Electrosurgical return electrode, single-use FDA UDICirculating immune complex (CIC) IVD, reagent 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 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-10653405031260 | 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 (13)
- EUDAMED 6a8b3128-04ca-4ce1-b37c-4867fea3cb13 61 fields · synced Jul 23, 2026
- EUDAMED 09eca11e-9d6c-43d7-a849-93d51d87547a 61 fields · synced May 17, 2026
- EUDAMED c44b71a2-cbe2-4026-a338-f07dd2ddc57f 61 fields · synced May 18, 2026
- EUDAMED a2e71702-221c-4209-a6fd-af6ce213c8e6 61 fields · synced May 18, 2026
- FDA UDI 228074d0-afa8-4869-aacc-87912ccf0a26 36 fields · synced May 30, 2026
- FDA UDI e2e4eeae-2e3d-4dda-86e5-5e7c075c41b2 36 fields · synced May 30, 2026
- FDA UDI 6983e18f-e223-48c0-8686-58aef039673d 37 fields · synced May 30, 2026
- FDA UDI 1835f2ff-263a-4d47-9663-e9e002122112 36 fields · synced May 30, 2026
- FDA UDI aca86f5c-3c89-461d-a795-f239b2b17dd1 37 fields · synced May 30, 2026
- EUDAMED d3b5164c-5c85-466f-92f1-f9905be0d25d 61 fields · synced Jul 8, 2026
- EUDAMED 5b2a0be6-bcad-47b3-9994-c676f7a9ce66 61 fields · synced Jul 18, 2026
- EUDAMED fd50e98b-4b29-441e-85a3-79528d1fa519 61 fields · synced Jul 21, 2026
- EUDAMED 9e92e5ee-8b2f-471f-9398-7f994678df67 61 fields · synced Jul 23, 2026