Identity
- Trade Name
- CHIN STRAPS-5 INCH FDA UDI
- Generic Name
- Analytical scalp lead FDA UDI
- Model / Reference
- E23-5 FDA UDI
Identifiers
- Catalog Number
- E23-5 FDA UDI
- Primary DI / UDI-DI
- 00811478012293 FDA UDI
- 510(k) Number
- K112319 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Analytical scalp lead 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
No
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
Yes
FDA UDI
Category: Analytical scalp lead
Chin Straps-5 Inch by Electro-Cap International Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K112319 also covers:
- BIO-POTENTIAL ELEC - SOCKETS — ELECTRO-CAP INTERNATIONAL INC
- BIOLOGIC CEEGRAPH CAP-MEDIUM — ELECTRO-CAP INTERNATIONAL INC
- BIOLOGIC CEEGRAPH CAP-XSM — ELECTRO-CAP INTERNATIONAL INC
- BODY HARNESS-MEDIUM — ELECTRO-CAP INTERNATIONAL INC
- BRAIN ATLAS CAP-SMALL — ELECTRO-CAP INTERNATIONAL INC
- BRAIN ATLAS CAP-X-SMALL — ELECTRO-CAP INTERNATIONAL INC
- CADWELL CAP-LARGE — ELECTRO-CAP INTERNATIONAL INC
- CADWELL EASY 2 SYS 2 SOCKETS — ELECTRO-CAP INTERNATIONAL INC
- CADWELL EASY2 CAP-EX SMALL — ELECTRO-CAP INTERNATIONAL INC
- CADWELL EASY2 INFA CAP 2 — ELECTRO-CAP INTERNATIONAL INC
- CADWELL EASY2 SYSTEM 1 — ELECTRO-CAP INTERNATIONAL INC
- CADWELL EASY2 SYSTEM 2 — ELECTRO-CAP INTERNATIONAL INC
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 |
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Manufacturer
- Manufacturer
- Electro-Cap International Inc
Sources (1)
- FDA UDI a978863f-a89a-4d29-9a64-c5bb10ca66af 35 fields · synced May 31, 2026