Identity
- Trade Name
- EchoBlock FDA UDI
- Generic Name
- Peripheral nerve-block blunt needle FDA UDI
- Device Name
- 21G x 3 1/8"(80mm) Facet tip, 30 degree bevel with fixed tubing FDA UDI
- Model / Reference
- EB-2180 FDA UDI
- Description
- 21G x 3 1/8"(80mm) Facet tip, 30 degree bevel with fixed tubing FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04526737170664 FDA UDI
- 510(k) Number
- K063380 FDA UDI
- FDA Product Code
- BSP FDA UDI
- GMDN Term
- Peripheral nerve-block blunt needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
- Needle Gauge — 21 Gauge FDA UDILength — 80 Millimeter FDA UDI
Category: Peripheral nerve-block blunt needle
EchoBlock by Hakko Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K063380 also covers:
- EchoBlock — HAKKO CO., LTD.
- EchoBlock — HAKKO CO., LTD.
- EchoBlock — HAKKO CO., LTD.
- EchoBlock MSK — HAKKO CO., LTD.
- EchoBlock MSK — HAKKO CO., LTD.
- EchoBlock MSK — HAKKO CO., LTD.
- EchoBlock MSK — HAKKO CO., LTD.
- EchoBlock MSK — HAKKO CO., LTD.
- EchoBlock MSK — HAKKO CO., LTD.
- EchoBlock MSK — HAKKO CO., LTD.
- EchoStim — HAKKO CO., LTD.
- EchoStim — HAKKO CO., LTD.
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
- Hakko Co., Ltd.
Sources (1)
- FDA UDI e3858f15-bee0-41f3-9c20-50ba23b774ac 36 fields · synced May 30, 2026