Identity
- Trade Name
- BRAINSTREAM FDA UDI
- Generic Name
- Analytical scalp electrode, single-use FDA UDI
- Device Name
- BRAINSTREAM DISPOSABLE DEEP CUP EEG ELECTRODES, 100 CM/40", 1.5 MM DIM CONNECTOR FDA UDI
- Model / Reference
- 72610-M-CM-10 FDA UDI
- Description
- BRAINSTREAM DISPOSABLE DEEP CUP EEG ELECTRODES, 100 CM/40", 1.5 MM DIM CONNECTOR FDA UDI
Identifiers
- Catalog Number
- 72610-M-CM-10 FDA UDI
- Primary DI / UDI-DI
- 20653405986659 FDA UDI
- 510(k) Number
- K200540 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Analytical scalp electrode, single-use 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 — 40 Inch FDA UDILength — 100 Centimeter FDA UDI
Category: Analytical scalp electrode, single-use
Brainstream by Conmed Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Analytical scalp electrode, single-use.
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Cleared under the same submission
K200540 also covers:
- BRAINSTREAM — Conmed Corporation
- BRAINSTREAM — Conmed Corporation
- BRAINSTREAM — Conmed Corporation
- BRAINSTREAM — Conmed Corporation
- BRAINSTREAM — Conmed Corporation
- BRAINSTREAM — Conmed Corporation
- BRAINSTREAM — Conmed Corporation
- BRAINSTREAM — Conmed Corporation
- BRAINSTREAM — Conmed Corporation
- BRAINSTREAM — Conmed Corporation
- BRAINSTREAM — Conmed Corporation
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
- Conmed Corporation
Sources (1)
- FDA UDI 7404b15b-fc1a-4058-a60b-811824c4a7f7 38 fields · synced May 30, 2026