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ECT Cotton Bite Blocks Size Large
EUDAMEDFDA UDIClass I (EU MDR)
Ref 9391-0003 L
Identity
- Trade Name
- Cotton Bite Block FDA UDI
- Generic Name
- Seizure bite block FDA UDI
- Device Name
- ECT Cotton Bite Blocks Size Large EUDAMEDMECTA ECT Cotton Bite Blocks Size Large FDA UDI
- Model / Reference
- 9391-0003 L EUDAMEDFDA UDI
- Description
- MECTA ECT Cotton Bite Blocks Size Large FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10850045508071 EUDAMEDFDA UDI
- Basic UDI-DI
- 10850045508071DJ EUDAMED
- 510(k) Number
- K201309 FDA UDI
- FDA Product Code
- JXL FDA UDI
- EMDN Code
- Z12109002 ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT EUDAMED
- GMDN Term
- Seizure bite block FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5070 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
ECT Cotton Bite Blocks Size Large by SigmaStim Domestic LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 10850045508071DJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- SigmaStim Domestic LLC
- EUDAMED SRN
- US-MF-000029359
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (2)
- EUDAMED 755d7262-0844-44ce-8a30-58b2541ad978 61 fields · synced Jun 18, 2026
- FDA UDI 03e926fe-9627-4e48-91ba-7b827fa9fc0d 34 fields · synced May 30, 2026